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Rare Diseases Imaging For Clinical Trials

Rare Diseases Imaging CRO

As a specialist imaging CRO for rare disease trials, we provide indication-specific imaging strategies, advanced quantitative MRI and pediatric-appropriate workflows designed for small, geographically dispersed patient populations.

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Years of Imaging Expertise!

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Clinical Trials Supported

Global

Site & Investigator Network

Compliance & Certificates

SOC 2 TYPE II

HHS-Seal

GDPR

FDA 21 CFR Part 11

ISO 13485

Protecting Every Scan in Small, Dispersed Patient Populations

Imaging endpoints in rare disease trials

Rare disease trials often face particular challenges in maintaining imaging consistency. Small patient populations may be distributed across multiple countries and sites, meaning that non-evaluable scans or variability in acquisition can have a disproportionate impact on the overall dataset.

Many rare diseases also require sensitive and reproducible measures of disease progression. Multisystem involvement, slowly evolving structural changes and pediatric study populations can make standardized quantitative imaging particularly valuable for longitudinal assessment.

IAG develops indication-specific imaging strategies using quantitative MRI, PET, CT and other advanced imaging approaches where appropriate. In Duchenne muscular dystrophy, for example, standardized quantitative muscle MRI can support assessment of muscle volume, fat infiltration and other disease-related changes, reducing reliance on repeated invasive procedures where appropriate.

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What our rare disease imaging team does

Rare Disease Imaging Capabilities

Indication-specific imaging strategy, quantitative muscle MRI, automated segmentation and fat–water analysis in DYNAMIKA™, and pediatric-appropriate imaging workflows.

Quantitative muscle MRI

Dixon-based imaging, T2 mapping and MR spectroscopy supporting quantitative assessment of muscle volume, intramuscular fat fraction and disease-related tissue changes.

Automated image analysis

Automated segmentation and fat–water separation workflows integrated within DYNAMIKA™ to support standardized quantitative analysis.

Pediatric-appropriate imaging workflows

Age-appropriate MRI and CT protocols designed to minimize radiation exposure where CT is required, manage motion and support child- and family-centered imaging pathways, including consideration of sedation requirements.

Study Phases

How Image Analysis Group Supports Rare Disease Trials

Imaging designed for small, dispersed cohorts — protecting every scan at every phase.

Collect & Hold

Prospective or retrospective collection image collection and secure archival — critical where cohorts are small and every timepoint counts.

Collect & Hold

Early Phase Trials

Quantitative muscle MRI and exploratory measures to establish sensitive markers of progression in small populations.

Early Phase Trials

Late Phase Trials

Standardized central analysis with automated segmentation and fat–water workflows, plus pediatric-appropriate imaging pathways.

Late Phase Trials

RWE & AI Studies

Submission-ready quantitative datasets, TFLs and variability analyses for rare disease and gene therapy programs.

RWE & AI Studies

The experts behind your reads

Rare Disease Imaging Experts

Neuromuscular trial investigators and cell and gene therapy leaders who define quantitative muscle MRI methodology and advise on regulatory strategy for rare disease programs.

Scientific Advisor — Cell & Gene Therapy, Advanced Therapies, Translational Medicine

Measures and modalities we work in

Quantitative Imaging Measures in Rare Disease

Intramuscular fat fraction, T2 mapping, muscle volume quantification, MR spectroscopy, organ volumetry and exploratory radiomics — applied where scientifically appropriate to the disease and endpoint.

Criterion

Applies to

Intramuscular fat fraction

Quantitative assessment of fatty infiltration in neuromuscular disease using Dixon-based MRI techniques

T2 mapping

Quantitative assessment of muscle tissue changes, including alterations associated with inflammation, increased free water and other disease-related processes

Muscle volume quantification

Longitudinal assessment of muscle volume and disease-related change in neuromuscular disorders

MR spectroscopy

Quantitative assessment of selected tissue metabolites in rare metabolic and neuromuscular disorders where relevant to the study objective

Radiomics and advanced image analysis

Exploratory quantitative assessment of tissue characteristics and organ involvement where scientifically appropriate to the disease and study objectives

Organ volumetry

Quantitative assessment of disease-related changes in organ volume where relevant to multisystem rare diseases

Indications we cover

Rare Disease Indications We Support

Duchenne muscular dystrophy and other neuromuscular disorders, rare metabolic and genetic disease, multisystem rare disease, pediatric imaging and cell and gene therapy studies.

Duchenne Muscular Dystrophy and Other Neuromuscular Disorders

Quantitative muscle MRI can track disease progression without repeated invasive procedures. We deliver Dixon-based intramuscular fat fraction, T2 mapping and muscle volume quantification with automated segmentation and fat–water separation in DYNAMIKA™.

Rare Metabolic Disorders

When cohorts number in the tens, every scan has to be evaluable. We standardize acquisition across widely dispersed sites and apply MR spectroscopy and organ volumetry matched to the disease mechanism.

Rare Genetic Disorders

Novel indications often have no established imaging endpoint. We develop indication-specific imaging strategies and exploratory quantitative measures, including radiomics where scientifically appropriate to the disease.

Multisystem Rare Diseases

Multi-organ involvement means multiple modalities and reader profiles in one protocol. We coordinate organ volumetry and cross-modality assessment through a single centralized platform and audit trail.

Pediatric Imaging

Children are not small adults when it comes to imaging protocol design. We build age-appropriate MRI and CT protocols that manage motion, minimise radiation exposure where CT is required, account for sedation, and support child- and family-centered imaging pathways.

Cell and Gene Therapy Studies

Single-administration therapies place enormous weight on a small number of imaging timepoints. We design imaging strategies with regulatory input and deliver standardized quantitative endpoints suitable for accelerated approval pathways.

One Platform Protecting Every Scan

Why Sponsors Choose Image Analysis Group

DYNAMIKA™ applies automated QC on receipt and automated segmentation and fat–water analysis to quantitative muscle MRI — critical when cohorts are small and every timepoint counts.

Centralized, secure data collection

DYNAMIKA™ unifies global imaging into a single cloud-native environment — GxP-validated, SOC 2 Type II and 21 CFR Part 11 compliant.

Real-time visibility and oversight

24/7 access to imaging status for every stakeholder, with site and reader performance tracked as the study runs.

Quality control and automated anonymization

Automated checks on receipt produce de-identified, QC-passed datasets before any read begins.

Consistent, standardized reads

Protocol-driven central reviews deliver standardized quantitative assessment of muscle volume, intramuscular fat fraction and other disease-relevant tissue measures, supported by automated segmentation and fat–water separation workflows within DYNAMIKA™.

Rare Diseases

Reader management and audit trails

Readers and analysts are qualified against the study-specific imaging and analysis methodology. Assignment, blinding and adjudication workflows are managed within the platform, with every action captured in a complete audit trail.

Rare Diseases

Reduced site burden, faster timelines

Simplified upload and query workflows shorten the gap between visit and usable data, and keep central reads inside the data-lock window.

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Talk to us about your rare disease imaging endpoint

Endpoint selection, charter design, or checking scanner capability at your sites — start with a conversation.