OSTEOARTHRITIS

End-to-End Support of Osteoarthritis Studies

MAKE OUR EXPERT TEAM YOUR NEW PARTNERS

Accelerate Recruitment: Every day in drug development counts as patients are waiting for new treatments. IAG’s streamlined processes and global network expedite clinical trials without compromising quality.

Expertise You Can Trust: IAG has a proven track record of tackling complex imaging challenges – from finding the right managing sites, integrating novel endpoints, assessing drug safety and supporting M&A discussions.

Global Support, Local Focus: We placed our team of imaging specialists in geographically important hubs (EU, Asia, USA), which enables us to provide efficient answers to the sites and support global trials, with speed.

Value-Driven Partnerships: We prioritize delivering the highest quality data at competitive cost. We thrive to build long term relationships with our partners and clients.

IAG’S QUALITY & EFFICIENCY

We understand the value of time and transparency in clinical development, and power our trials with DYNAMIKA platform. It is designed to efficiently process imaging data, support all trial stakeholders, deliver results via reports or dashboards. Thus, helping our partners, readers and sponsors to fast decisions.

As an example, IAG was contacted by the USA based global pharmaceutical company to support their phase II clinical trial. The objective was to collect DCE-MRI scans from globally distributed sites and assess their drug for efficacy. Dynamic Contrast Enhanced MRI was used to assess the inflammatory changes.

 

Our sponsor has chosen us for our expertise in the field, our global network, and our proprietary platform where analysis was made in real-time, and the result was shared with the different parties.

The work involving 60 patients, which were analysed with IAG’s proprietary analysis technique showing that in this trial of patients with osteoarthritis, significant improvement in sub-clinical, synovial-based inflammation after 6 months of therapy was detected with this novel MRI-based quantitative tool.

KEY TO OA STUDY SUCCESS

Accessibility: IAG has worked with many imaging facilities and can recommend high-performing Imaging Sites for your study, reducing risk and improving patient recruitment.

Transparency: DYNAMIKA is a proprietary, secure image transfer and processing system that provides real-time access to tracking information throughout the study.

Speed: X-ray scans acquired at screening have to be read and adjudicated with speed. IAG provides reports to the sites within 1-5 days, allowing accelerated recruitment.

Disease Modification: When deploying advanced imaging (MR, PET, CT) to assess drug efficacy, we ensure that we can advice on the optimal endpoints and support regulatory discussions.

Would you be interested in receiving regular updates and
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MULTIPLE SITES & ONE STUDY: SIMPLIFY THE DATA MANAGEMENT

Managing data across multiple sites in clinical trials can be complex and time-consuming. Recognizing this challenge, our team of experts developed DYNAMIKA. It is IAG’s proprietary enterprise-scale cloud-based platform for imaging processing and data management. It works across multi-centre trial settings to enable central imaging review.​ This one comprehensive software system controls trial progress, conducts central reads and, when needed, it can be integrated with AI tools for earlier read-outs and decision support. Read more here.

MORE THAN A PARTNER, AN EXTENSION OF YOUR TEAM

Image Analysis Group is a unique partner to life sciences companies. Our goal is to accelerate novel drug developments, by using the right analytical tools and a modern trial infrastructure. At IAG, we are committed to helping our biotech and pharma partners to efficiently develop novel life-changing medicines, accelerating their R&D pipelines through advanced analytics, IAG’s technology solutions and imaging contract research services. We see each project as an oportunity to build a long lasting partnership and to become an extension of your team.

If you have any inquiries or require assistance,
please do not hesitate to reach out to us!

Image Analysis for Gout Clinical Trials

End-to-End Support of Gout Studies

 

MAKE OUR EXPERT TEAM YOUR NEW PARTNERS

Shorten Time to Market: Every day in drug development counts as patients are waiting for new treatments. IAG’s streamlined processes and global network expedite clinical trials without compromising quality.

Expertise You Can Trust: IAG has a proven track record of tackling complex imaging challenges – from managing sites, resolving queries, integrating novel endpoints and supporting overall stakeholder collaboration.

Global Support, Local Focus: We placed our team of imaging specialists in geographically important hubs (EU, Asia, USA), which enables them to provide efficient answers to the sites and support global trials, with speed.

Value-Driven Partnerships: We prioritize delivering the highest quality data at competitive cost. We thrive to build long term relationships with our partners and clients.

IAG’S QUALITY & EFFICIENCY

We understand the value of time and transparency in clinical development, and power our trials with DYNAMIKA platform. It is designed to efficiently process imaging data, support all trial stakeholders, deliver results via reports or dashboards. Thus, helping our partners, readers and sponsors to fast decisions.

As an example, IAG was contacted by the USA based global pharmaceutical company to support their phase II clinical trial. The objective was to collect DCE-MRI and DECT scans from globally distributed sites and assess their drug for efficacy. DECT was used to assess impact of the drug on crystal resolution. Dynamic Contrast Enhanced MRI was used to assess the inflammatory changes.

Our sponsor has chosen us for our expertise in the field, our global network, and our proprietary platform where analysis was made in real-time, and the result was shared with the different parties.

The work involving 25 patients, which were analysed with IAG’s proprietary analysis technique was  published as  ‘A Post-Hoc Analysis of the Synovial-Based Inflammation During Inter-Critical Gout Using A Novel Semi-Automatic Quantitative MRI Tool‘, showing that in this post-hoc analysis of patients with inter-critical gout, significant improvement in sub-clinical, synovial-based inflammation after 9 months of ULT was detected with this novel MRI-based quantitative tool. This technique deserves further study as a potential tool to assess inter-critical gout.

KEY TO GOUT STUDY SUCCESS

Reproducibility: Properly acquired and correctly analysed advanced imaging scans result in very low precision error which allows detection of subtle changes over time.

Harmonisation: Capturing phantom scans and monitoring image output across different imaging equipment vendors over the course of your study is vital to have a consistent data output.

Accessibility: IAG has worked with many imaging facilities and can recommend high-performing Imaging Sites for your study, reducing risk and improving patient recruitment.

Transparency: DYNAMIKA is a proprietary, secure image transfer and processing system that provides real-time access to tracking information throughout the study.

 

Would you be interested in receiving regular updates and
staying informed with the latest news?
We invite you to subscribe to our newsletter.

MULTIPLE SITES & ONE STUDY: SIMPLIFY THE DATA MANAGEMENT

Managing data across multiple sites in clinical trials can be complex and time-consuming. Recognizing this challenge, our team of experts developed DYNAMIKA. It is IAG’s proprietary enterprise-scale cloud-based platform for imaging processing and data management. It works across multi-centre trial settings to enable central imaging review.​ This one comprehensive software system controls trial progress, conducts central reads and, when needed, it can be integrated with AI tools for earlier read-outs and decision support. Read more here.

MORE THAN A PARTNER, AN EXTENSION OF YOUR TEAM

 

Image Analysis Group is a unique partner to life sciences companies. Our goal is to accelerate novel drug developments, by using the right analytical tools and a modern trial infrastructure. At IAG, we are committed to helping our biotech and pharma partners to efficiently develop novel life-changing medicines, accelerating their R&D pipelines through advanced analytics, IAG’s technology solutions and imaging contract research services. We see each project as an oportunity to build a long lasting partnership and to become an extension of your team.

If you have any inquiries or require assistance,
please do not hesitate to reach out to us!

Streamlined DXA Image Analysis for Clinical Trials

End-to-End Support of Studies involving DXA:

Osteoporosis, Oncology, Infection disease, Nutrition and Metabolism Studies and more

Streamlined DXA Analysis for Clinical Trials

Did you miss our live discussion?

Watch this webinar here.

MAKE OUR EXPERT TEAM YOUR NEW PARTNERS

Shorten Time to Market: Every day in drug development counts as patients are waiting for new treatments. IAG’s streamlined processes and global network expedite clinical trials without compromising quality.

Expertise You Can Trust: IAG has a proven track record of tackling complex imaging challenges – from managing sites, resolving queries, integrating novel endpoints and supporting overall stakeholder collaboration.

Global Support, Local Focus: We placed our team of imaging specialists in geographically important hubs (EU, Asia, USA), which enables them to provide efficient answers to the sites and support global trials, with speed.

Value-Driven Partnerships: We prioritize delivering the highest quality data at competitive cost. We thrive to build long term relationships with our partners and clients.

QUALITY & EFFICIENCY

IAG’s team experience with using DXA and X-ray in clinical trials spans over 40 years, with the company supporting large registrational studies and research PoC projects, since 2016. We understand the value of time and transparency in clinical development, and power our trials with DYNAMIKA platform. It is designed to efficiently process imaging data, support all trial stakeholders, deliver results via reports or dashboards. Thus, helping our partners, readers and sponsors to fast decisions.

Read our case studies: from saving significant budgets: ‘35% Trial Budget Reduction’ to ‘Reducing Length & Cost of Trials through Patient Stratification‘.

Case Study: One specific study, involving DXA analysis makes a vivid example. In 2021, IAG was contacted by a large European biotech company to support their Phase III trial. The objective was to utilize X-ray and DXA scans for combined eligibility as one of the criteria for the inclusion / exclusion of patients in their protocol. The Sponsor was looking for experts in the field, who can bring global network of sites, and execute screening with speed. IAG’s team partnered with the CRO and together we embarked on accelerating recruitment. The Study recruited faster than exepcted, saving Sponsor significant time and money. The data is currently being finalized to be submitted for regulatory review.

+1200 patients

+50 Sites in all Europe

0.4 day from the upload to the QC report

2.2 days from QC report to Final Report

DYNAMIKA
hosted all the DXA and X-ray images and analysis

KEY TO DXA STUDY SUCCESS

Reproducibility: Properly acquired and correctly analysed DXA scans result in very low precision errors, allowing the detection of subtle changes over time.

Validity: Evaluating and monitoring instrument calibration throughout your study is vital for validating patient BMD results. IAG ensures that Instrument Quality Control (IQC) data are collected correctly and available for analysis to support patient results.

Accessibility: IAG has collaborated with numerous imaging facilities and can recommend high-performing DXA sites for your study, reducing risk and improving patient recruitment.

Transparency: DYNAMIKA is a proprietary, secure image transfer and processing system that provides real-time access to tracking information throughout the study.

Would you be interested in receiving regular updates and
staying informed with the latest news?
We invite you to subscribe to our newsletter.

MULTIPLE SITES & ONE STUDY: SIMPLIFY THE DATA MANAGEMENT

Managing data across multiple sites in clinical trials can be complex and time-consuming. Recognizing this challenge, our team of experts developed DYNAMIKA. It is IAG’s proprietary enterprise-scale cloud-based platform for imaging processing and data management. It works across multi-centre trial settings to enable central imaging review.​ This one comprehensive software system controls trial progress, conducts central reads and, when needed, it can be integrated with AI tools for earlier read-outs and decision support. Read more here.

MORE THAN A PARTNER, AN EXTENSION OF YOUR TEAM

Image Analysis Group is a unique partner to life sciences companies. Our goal is to accelerate novel drug developments, by using the right analytical tools and a modern trial infrastructure. At IAG, we are committed to helping our biotech and pharma partners to efficiently develop novel life-changing medicines, accelerating their R&D pipelines through advanced analytics, IAG’s technology solutions and imaging contract research services. We see each project as an oportunity to build a long lasting partnership and to become an extension of your team.

If you have any inquiries or require assistance,
please do not hesitate to reach out to us!

SCLERODERMA

SCLERODERMA

SCLERODERMA

Scleroderma, a rare and often perplexing autoimmune disorder, presents numerous challenges for both patients and drug development organizations. One key tool in unravelling the mysteries of this condition is medical imaging. From diagnosing scleroderma to monitoring disease progression and assessing treatment effectiveness, various imaging modalities play a crucial role in the care of individuals affected by this disease.

IAG team helps pharmaceutical companies to use medical imaging and associated digital endpoints to support diagnosis / screening, assessment of organ involvement, disease progression monitoring and drug efficacy assessment using MRI, US, Xray, CT and other available imaging modalities.

IAG and University of Leeds, UK have partnered to develop a novel Digital Arteries Volume Index, DAVIX, which was used in drug development trials since 2010. DAVIX© has been validated as a predictor of the onset of Digital Ulcers in Systemic Sclerosis patients. This innovative methodology is based on the Time-of-Flight Magnetic Resonance Imaging (MRI) angiography and allows to quantitatively assess digital arterial blood flow.

  1. Screening: Scleroderma’s hallmark symptom is skin thickening, but it can also affect internal organs, making early and accurate diagnosis critical. Imaging, such as high-resolution ultrasound and magnetic resonance imaging (MRI), is instrumental in detecting abnormalities within affected tissues and organs. These techniques help clinicians visualize the extent and location of fibrosis, a key feature of scleroderma, and can aid in differentiating the disease from other conditions with similar symptoms.
  2. Assessing Organ Involvement: Scleroderma doesn’t stop at the skin; it often targets vital organs such as the lungs, heart, and gastrointestinal tract. Imaging studies like chest X-rays, CT scans, and echocardiograms can provide vital information about the extent of organ involvement, helping doctors tailor treatment plans to individual patients.
  3. Disease Progression Monitoring: Scleroderma is a progressive disease, and regular monitoring is essential to track changes in organ function and tissue involvement. Imaging allows for ongoing assessment without invasive procedures, providing valuable data for treatment adjustments and long-term management.
  4. Evaluating Treatment Efficacy: Many treatment options are available to manage scleroderma, but their effectiveness varies from person to person. Imaging can help healthcare providers gauge how well treatment is working by tracking changes in organ function, tissue thickness, and inflammation levels.

Imaging plays a pivotal role in scleroderma research. By visualizing the disease at the cellular and molecular levels, scientists can gain deeper insights into its underlying mechanisms and develop more targeted therapies.

IAG’s team plays an active role in the scientific community and have led the development of novel scoring systems for early assessment of synovial inflammatory changes, quantification of inflammation (bone marrow oedema and synovial) and quantitative assessment of erosive changes.

About IAG, Image Analysis Group

IAG is a unique partner to life sciences companies developing new treatment and driving the hope of the up-coming precision medicine. IAG leverages expertise in medical imaging and the power of DYNAMIKA™ , our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes.

Acting as imaging Contract Research Organization, IAG’s experts also recognize the significance of a comprehensive approach to asset development. They actively engage in co-development projects with both private and public sectors, demonstrating a commitment to cultivating collaboration and advancing healthcare solutions.

Contact our expert team: imaging.experts@ia-grp.com

READ NEXT CASE STUDY >
Experience: Scoring Systems
  • Eligibility and Safety Assessments
  • DAVIX (Digital Arteries Volume Index)
  • Quantitative Inflammation (DEMRIQ)
  • Organ Involvement (Xray or CT)
  • US-Doppler Quantification
Experience: Imaging
  • MRI
  • DCE-MRI
  • CT
  • X-ray
  • Ultrasound
Publications

Since 2007, over 2000 articles were published to cover scientific discoveries, technology break-throughs and special cases. We list here some critically important papers and abstracts.

Testimonials

Combining our technologies and business advisory services with promising life science companies has yielded spectacular results over the past five years. As a trusted partner to many biotech and pharma companies, IAG’s team is proud to share your words and quotes.

RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS

Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease characterised by joint inflammation, with consequent tissue damage and destruction that causes pain, deformity and disability to those affected. Patients are treated with painkillers and a range of disease-modifying anti-rheumatic drugs (DMARDs), the trend being for older generic small molecules at first-line moving to newer biologic drugs as disease severity progresses. The market for RA drugs represents one of the highest value pharmaceutical markets. Specifically, the growth and large size of the market have been driven by revenues from novel, highly priced, biologic drugs. The first biologic approved for the treatment of RA was Amgen’s anti-TNF fusion protein Enbrel® (etanercept) in 1998 (US) and since that time a number of others have reached the market, their combined sales hitting nearly $40 billion in 2015. Biologic drugs currently dominate the market, so there is certainly space to innovate with advanced therapies and small molecules.

In monitoring RA, different clinical scores (i.e., DAS28) reflect the clinical disease activity. Clinical scores are limited and often despite of clinical remission, radiographic progression is possible, and the erosive process predicts the outcome of the disease. Objective imaging modalities are necessary to detect the destructive process as early as possible.

IAG’s team has extensive expertise and track record in supporting the development of RA’s blockbusters and helping to take these drugs from early phase all the way to phase 3 and approval. Our expertise is in use of

  • X-ray
  • MRI
  • Dynamic Contrast Enhanced MRI
  • CT
  • PET (FDG and other tracers)

IAG’s team plays an active role in the scientific community and have led the development of novel scoring systems for early assessment of synovial inflammatory changes, quantification of inflammation (bone marrow oedema and synovial) and quantitative assessment of erosive changes.

About IAG, Image Analysis Group

IAG is a unique partner to life sciences companies developing new treatment and driving the hope of the up-coming precision medicine. IAG leverages expertise in medical imaging and the power of DYNAMIKA™, our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes.

Acting as imaging Contract Research Organization, IAG’s experts also recognize the significance of a comprehensive approach to asset development. They actively engage in co-development projects with both private and public sectors, demonstrating a commitment to cultivating collaboration and advancing healthcare solutions.

Contact our expert team: imaging.experts@ia-grp.com

READ NEXT CASE STUDY >
Experience: Scoring Systems
  • Eligibility and Safety Assessments
  • RA MRI Score (RAMRIS)
  • Quantitative Inflammation (DEMRIQ)
  • Radiographic Progression (Xray or CT)
  • Erosive Volume
  • US-Doppler Quantification
Experience: Imaging
  • MRI
  • DCE-MRI
  • CT
  • X-ray
  • PET, PET-CT
  • Ultrasound, US-Doppler
  • MARs Imaging
Publications

Since 2007, over 2000 articles were published to cover scientific discoveries, technology break-throughs and special cases. We list here some critically important papers and abstracts.

Testimonials

Combining our technologies and business advisory services with promising life science companies has yielded spectacular results over the past five years. As a trusted partner to many biotech and pharma companies, IAG’s team is proud to share your words and quotes.

OSTEOARTHRITIS

OSTEOARTHRITIS

OSTEOARTHRITIS

Osteoarthritis (OA) is considered to be a disease of the cartilage in the joints even though it involves the whole joint, including the bone and synovium (thin lining of the joints which produces synovial fluid). With time, more and more of the cartilage is destroyed by the disease with inflammation commonly occurring. The treatment of knee OA is currently restricted to management of pain and function with low-to-moderate efficacy. A number of pain medications is being developed and already approved. To be registered as a DMOAD, companies must demonstrate their drug candidates alter the structural progression of OA. The FDA and the European Medicines Agency’s Committee for Medicinal Products for Human Use have DMOAD development guidelines and although considerable time has passed since their issue (FDA draft guidance in 1999, CHMP guidance in 2010), they are still in effect today.

In 2010, a Structural Change Working Group from The Osteoarthritis Research Society International (OARSI) provided recommendations to the FDA concerning finalizing the its 1999 draft guidance (at the FDA’s request), but a final guidance document was never issued.

The FDA’s draft guidance and CHMP’s guidance state that the only acceptable primary endpoint for DMOAD pivotal studies is Joint Space Narrowing (JSN, preferably of the knee or hip), measured by X-ray.

JSN is defined as decreasing Joint Space Width (JSW) and represents a surrogate measure for the thickness of cartilage in a joint.

Both guidance documents outline what pivotal study parameters are required for drugs to carry either a label for “treatment of symptoms” or “structure modifying/delay in structural progression” (contact our team for further information).

Developers are also required by both agencies to demonstrate that a DMOAD should have an effect on both structure and patient-reported clinical benefit (symptoms and/or function). The effects of a potential DMOAD on symptom modification may be assessed in a separate clinical trial of shorter duration.

…though there are some limitations to JSN…

 

Although JSN is still the mandatory primary endpoint for structural modification, we note that it does have limitations, some of which present challenges to developers:

  • JSN changes are generally slow and variable between subjects, necessitating large and lengthy clinical trials;
  • It is difficult to obtain high quality reproducible X-rays of joints despite standardization of protocols to reduce variability in joint positioning;
  • OA is a disease that affects multiple tissues within a joint and is not purely the loss of cartilage. JSN by X-ray cannot visualize cartilage or other tissues and therefore potential early beneficial changes in joint tissues may be missed when using JSN alone; and
  • It remains unclear what change in JSN is clinically relevant to a patient. A number of agents (including glucosamine and chondroitin sulphate) have demonstrated superior JSN vs. placebo, but with either no or clinically irrelevant improvement in symptoms/function.

… MRI is becoming increasingly important

In the last two decades, there have been significant advances in magnetic resonance imaging (MRI) within the OA field. The primary attraction of MRI in OA is the ability to analyze multiple tissues of a joint, with the possibility of detecting structural changes early in the disease process.

In the OARSI Structural Change Working Group’s 2010 review of FDA guidance, it was recommended that MRI be used in clinical trials for cartilage morphology assessment and that the study of all joint tissues (possible by MRI) is important.

However, the Group acknowledged that a greater understanding of cartilage change quantitation, performance metrics of non-cartilage features and correlations of morphological changes with symptoms were needed, a view shared by the CHMP in its 2010 guidelines.

We believe that the successful use of MRI-based secondary endpoints in DMOAD development will strengthen a marketing application where JSN is the primary endpoint for structural modification. With continued growth in MRI research in OA, it is feasible that an MRI primary endpoint will be adopted in the future.

…as evidenced by Phase II trials of potential DMOADs

We note that three of the potential DMOADs in the OA Phase II clinical pipeline are being evaluated in clinical trials with an MRI-based primary endpoint, suggesting developers prefer MRI to JSN by x-ray for an initial assessment of drug efficacy.

For a symptom relief label, WOMAC has supported the most recent approval

Some early studies may consider using KOOS

IAG’s team has extensive experience in supporting OA drug development. Our team plays an active role in the scientific community and have led the development of novel scoring systems and formed strong collaborations with the industry’s Key Opinion Leaders as well as regulatory consultants and agencies.

We bring deep knowledge to help designing a trials, global experienced operations team and fully integrated cloud platform to support a trial that may require use of:

  • Xray
  • MRI
  • Dynamic Contrast Enhanced MRI
  • CT
  • PET / CT

About IAG, Image Analysis Group

IAG is a unique partner to life sciences companies developing new treatment and driving the hope of the up-coming precision medicine. IAG leverages expertise in medical imaging and the power of DYNAMIKA™, our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes.

Acting as imaging Contract Research Organization, IAG’s experts also recognize the significance of a comprehensive approach to asset development. They actively engage in co-development projects with both private and public sectors, demonstrating a commitment to cultivating collaboration and advancing healthcare solutions.

Contact our expert team: imaging.experts@ia-grp.com

READ NEXT CASE STUDY >
Experience: Scoring Systems
  • Proprietary: Automated Joint Space Width (JSW)
  • Proprietary: Automated Joint space Narrowing (JSN)
  • Proprietary: T2 Mapping (Cartilage Quality)
  • Proprietary: Inflammation Quantification (DEMRIQ)
  • Proprietary: Volumetric and Morphological Changes of Cartilage
  • Proprietary: Assessment of Muscle Changes
  • Proprietry: Bone Marrow Oedema Quantification

 

  • Kellgren-Lawrence Grade (KLG)
  • OARSI
  • Whole Organ MRI
  • BLOCKS
  • MOAKS
  • 11-point synovitis
  • WORMS
  • MOCART
  • CROAKS
  • dGEMRIQ
  • ADC / Cellular Density
  • Cartilage Volume
Experience: Imaging
  • X-ray
  • MRI
  • DCE-MRI
  • T2*
  • T2 Cartilage imaging
  • Ultrasound
  • CT
  • PET / CT
Publications

Since 2007, over 2000 articles were published to cover scientific discoveries, technology break-throughs and special cases. We list here some critically important papers and abstracts.

Testimonials

Combining our technologies and business advisory services with promising life science companies has yielded spectacular results over the past five years. As a trusted partner to many biotech and pharma companies, IAG’s team is proud to share your words and quotes.

OSTEOPOROSIS

OSTEOPOROSIS

OSTEOPOROSIS

It is estimated that more than 200 million people are suffering from osteoporosis and according to the International Osteoporosis Foundation 1 in 3 women over the age of 50 years and 1 in 5 men will experience osteoporotic fractures in their lifetime.

The prevalence of osteoporosis among adults aged 50 and over increased from 9.4% in 2008 to 12.6% in 2018

A silent health condition is often only revealed in case of fracture. It’s a chronic, progressive disease of multifactorial etiology. It has been most frequently recognized in elderly white women, although it does occur in both sexes, all races, and all age groups.The implications on mortality and morbidity associated with osteoporotic fractures are significant; the mortality rate in an elderly person with a hip fracture approaches 20%.

Osteoporosis has a substantial economic burden on countries; the direct annual cost of treating osteoporotic fractures people is, on average, between 5.0 to 6.5 billion USD in Canada, Europe, and the USA alone, not taking into account indirect costs.

Prevention and treatment of osteoporosis is a massive challenge for Healthcare and Pharmaceutical industry.

… DXA

Osteoporosis [Porous Bone] is a systemic skeletal disease characterized by low bone density (Quantity) and microarchitectural deterioration of bone tissue (Quality), with a consequent increase in bone fragility. To measure the Bone Mineral Density (BMD) – DXA, also called dual-energy X-ray absorptiometry (DEXA), or bone densitometry, the “Gold-standard” for BMD measurement, the most accurate and standardized way to measure Bone Mineral Density (BMD).

As a mainly numerical imaging modality, DXA relies on the precision of its measurements, especially in clinical trials.

Dynamika allows seamless integration with the main DXA manufacturers enabling a central reading and a consistent outline for the Regions of Interest, essential for the accuracy of the results across different sites.
Able to use different reference populations for T-score calculations, Dynamika is a platform ready for DXA studies independently of its world location.

What is osteoporosis?

Osteoporosis or Low Bone Mass in Older Adults.

Economic burden of osteoporosis.

What is osteoporosis?

About IAG, Image Analysis Group

IAG is a unique partner to life sciences companies developing new treatment and driving the hope of the up-coming precision medicine. IAG leverages expertise in medical imaging and the power of DYNAMIKA™, our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes.

Acting as imaging Contract Research Organization, IAG’s experts also recognize the significance of a comprehensive approach to asset development. They actively engage in co-development projects with both private and public sectors, demonstrating a commitment to cultivating collaboration and advancing healthcare solutions.

Contact our expert team: imaging.experts@ia-grp.com

READ NEXT CASE STUDY >
Publications

Since 2007, over 2000 articles were published to cover scientific discoveries, technology break-throughs and special cases. We list here some critically important papers and abstracts.

Testimonials

Combining our technologies and business advisory services with promising life science companies has yielded spectacular results over the past five years. As a trusted partner to many biotech and pharma companies, IAG’s team is proud to share your words and quotes.

LUMBAR DISC DISEASE / SPINE

LUMBAR DISC DISEASE / SPINE

LUMBAR DISC DISEASE / SPINE

Lumbar disk disease may occur when a disc in the low back area of the spine bulges or herniates from between the bony area of the spine. Lumbar disk disease causes lower back pain and leg pain and weakness that is made worse by movement and activity. Degenerative disc disease in the lumbar spine, or lower back, refers to a syndrome in which age-related wear and tear on a spinal disc causes low back pain.

Low back pain (LBP) is the leading cause of disability in developed countries, with the number of people affected worldwide increasing annually.

Back pain is believed to originate from a multitude of lumbar spinal structures including ligaments, facet joints, vertebral periosteum, paravertebral musculature and fascia, blood vessels, annulus fibrosus, and spinal nerve roots.

Therefore, imaging of the lumbar spine has an established role in the evaluation of the LBP patient, and within the last few decades, almost every medical imaging modality has been applied in the evaluation of LBP.

Radiography

Radiography can visualize bony structures and can be used in suspected cases of traumatic, osteoporotic or pathologic vertebral fractures, malalignment, congenital defects, and late stages of inflammatory and infectious diseases. It is an inexpensive and we often recommend it in the initial screening of the spine.

In many of our studies, discography is applied to increase diagnostic accuracy for detecting painful disc levels in LBP with low false-positive rates.

Computed tomography (CT)

Computed tomography (CT) uses a 3D tomographic radiographic technique and is the standard of reference for imaging the vertebral bones, facet joints degeneration, and soft tissue calcification. Tissue contrast on CT is optimal in very dense structures such as bone. Dense soft tissues like tendons, ligaments, and annulus fibrosus can also, to some degree, be differentiated. This makes CT ideal for trauma imaging and fracture characterization in the spine.

We work with a number of CT and DUAL-energy CT (DECT) sites to ensure a new treatment impact has been captured through assessment of the morphology or the chemical composition of the different tissues. Some of the studies include multispectral CT scanners so that our clients have an opportunity to assess change sin bone marrow edema, ligaments, and tendons.

MRI of the lumbar spine

The usual MRI protocols of the lumbar spine include sagittal T1-weighted (T1w) turbo/fast spin echo (TSE/FSE), sagittal and axial T2-weighted (T2w), TSE/FSE images. Adding a sequence in the coronal plane at a later stage has been recommended to allow a better visualization of transitional vertebras, extraforminal disc herniations, extraforaminal nerve roots compression, degenerative vertebral translation, and paravertebral osteophytes.

The presence of fatty tissue in the bone marrow may obscure underlying pathologies on the T2w images without fat saturation. To overcome this issue, spectral fat suppression T2w or fluid sensitive such as the Short Tau Inversion Recovery (STIR) sequences have been used. In STIR sequences, fluid is bright because the contrast is a combination of T1w and T2w images. STIR is the most robust fat-suppression technique in the lumbar spine sensitive for detection of edema and may serve as a screening sequence for many neoplastic, infectious, and traumatic pathologies. However, it is less useful for degenerative conditions because of a high degree of noise and low resolution.

We also design protocols and assess changes using DIXON and DCE-MRI sequences, thus giving more precise information on the pain and inflammation.

IAG’s team has extensive experience in supporting Lower Back Pain, Disc Degeneration ad other Spine disease. Our team plays an active role in the scientific community and have led the development of novel scoring systems and formed strong collaborations with the industry’s Key Opinion Leaders as well as regulatory consultants and agencies.

We bring deep knowledge to help designing a trials, global experienced operations team and fully integrated cloud platform to support a trial that may require use of:

  • Xray
  • MRI, Dynamic Contrast Enhanced MRI, DIXON, STIR
  • CT, PET / CT

About IAG, Image Analysis Group

IAG is a unique partner to life sciences companies developing new treatment and driving the hope of the up-coming precision medicine. IAG leverages expertise in medical imaging and the power of DYNAMIKA™, our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes.

Acting as imaging Contract Research Organization, IAG’s experts also recognize the significance of a comprehensive approach to asset development. They actively engage in co-development projects with both private and public sectors, demonstrating a commitment to cultivating collaboration and advancing healthcare solutions.

Contact our expert team: imaging.experts@ia-grp.com

READ NEXT CASE STUDY >
Experience: Scoring Systems
  • MODIC
  • Disc morphology
  • Inflammation
  • Modified Pfirrmann score
  • Disc Height
  • Spinal Deformity
  • DEMRIQ
Experience: Imaging
  • X-ray
  • MRI
  • DCE-MRI
  • Ultrasound
  • CT
  • PET / CT
Publications

Since 2007, over 2000 articles were published to cover scientific discoveries, technology break-throughs and special cases. We list here some critically important papers and abstracts.

Testimonials

Combining our technologies and business advisory services with promising life science companies has yielded spectacular results over the past five years. As a trusted partner to many biotech and pharma companies, IAG’s team is proud to share your words and quotes.