Gastroenterologist in front of abdominal CT, MR enterography, and endoscopy monitors

Gastroenterology & Metabolic Imaging

Our Gastroenterology Imaging division provides specialized imaging and independent review expertise for clinical trials evaluating gastrointestinal, hepatobiliary, pancreatic, metabolic, and related abdominal and pelvic disorders. Supported by a network of more than 60 board-certified and fellowship-trained gastroenterologists, the Gastroenterology Imaging division combines deep clinical subspecialty expertise with rigorous imaging and assessment methodologies designed to produce consistent, reproducible, and clinically meaningful data across multicenter and global clinical trials. Our abdominal MRI expertise extends to metabolic and renal endpoints, including DXA and MRI body composition in obesity trials and total kidney volume in polycystic kidney disease.

Our experience spans a broad range of acute and chronic gastrointestinal conditions, including inflammatory bowel disease, ulcerative colitis, gastroesophageal reflux disease, short bowel syndrome, gastrointestinal ulcerative disease, and other complex disorders in which imaging, endoscopic evaluation, and objective assessment may play an important role in evaluating disease activity, progression, and therapeutic response.

The Gastroenterology Imaging division supports a comprehensive range of imaging and diagnostic modalities, including CT and high-resolution CT, low-dose and advanced CT techniques, MRI, endoscopy, and nuclear imaging with quantitative methodologies. Intrinsic Imaging works collaboratively with sponsors to develop study-specific imaging strategies encompassing protocol development, imaging charter design, site and reader qualification, acquisition standardization, image and endoscopy quality control, centralized independent review, quantitative assessment, adjudication, and regulatory-ready data delivery.

Particular attention is given to minimizing inter-site and inter-reader variability and maintaining consistent assessment methodologies across longitudinal timepoints—critical considerations when imaging or endoscopic findings contribute to efficacy, safety, disease-activity, or exploratory biomarker endpoints. By integrating experienced gastroenterology specialists with disciplined central-review processes and sophisticated imaging capabilities, Intrinsic Imaging provides the scientific, clinical, and operational expertise required to support complex gastroenterology clinical development programs from early-phase investigation through pivotal trials.

Gastroenterology Imaging Division Highlights

Extensive experience in providing services in support of clinical trials involving the GI system.
60+ board-certified and fellowship-trained gastroenterologists.
Experience in imaging of organ specific endocrine disorders as well as multiple endocrine syndromes and neoplasia.
Modality expertise includes:
- CT including novel techniques
- Endoscopy
High Resolution CT imaging and low dose techniques.
- MRI
- Nuclear imaging with quantitative techniques

Central Endoscopy and GI Imaging Review

Our GI imaging and endoscopy core lab provides centralized independent review of endoscopy and imaging for inflammatory bowel disease, ulcerative colitis, GERD, short bowel syndrome, ulcerative disease, and other gastrointestinal and abdominal disorders where objective assessment of disease activity matters.

CT, MRI and Quantitative Nuclear Imaging

We support high-resolution and low-dose CT, advanced CT techniques, MRI, endoscopy, and nuclear imaging with quantitative methodologies, with study-specific acquisition standards and image and endoscopy quality control.

Consistent Assessment Across Sites and Timepoints

Site and reader qualification, adjudication, and consistent methodology across longitudinal timepoints minimize inter-site and inter-reader variability for efficacy, safety, disease-activity, and exploratory biomarker endpoints.

IBD, Liver Disease and Quantitative Abdominal Imaging

GI studies often combine endoscopy, cross-sectional imaging and tissue assessment. We define each assessment separately and coordinate their acquisition, independent review and data delivery around the protocol.

Study focus	Methods	Central assessment
Crohn’s disease	Ileocolonoscopy and MR enterography	SES-CD, CDEIS and MaRIA or simplified MaRIA, as specified by the protocol
Ulcerative colitis	Endoscopy	Mayo endoscopic subscore and UCEIS
Steatotic liver disease and MASH	MRI-PDFF and MR elastography	Liver fat fraction and stiffness, with acquisition and analysis controls
Liver fibrosis	MR or ultrasound elastography	Protocol-defined stiffness measurements and longitudinal change
GI tissue endpoints	Digital pathology and histopathology review	Protocol-defined tissue scores, including Robarts or Nancy indices where applicable
Abdominal disease and GI tumors	CT, MRI, ultrasound and nuclear imaging	Anatomic, functional and lesion-based imaging measures

Central Endoscopy Scoring and Video Quality

Site instructions define required segments, video recording, mucosal visualization and labeling. Central quality control checks completeness and whether the recording supports the selected score. Gastroenterologists qualify on representative cases and apply blinded review and adjudication rules to reduce variation between sites and readers.

MR Enterography and Crohn’s Disease Activity

MR enterography protocols address bowel preparation, distension, coverage and required sequences. Readers evaluate wall thickening, edema, enhancement and ulceration using the protocol’s MaRIA-based method. Imaging scores are kept distinct from endoscopic and clinical activity measures, with clear rules for segment matching and missing assessments.

Liver Fat, Stiffness and Tissue Endpoints

MRI proton density fat fraction (MRI-PDFF) measures liver fat using standardized acquisition and region selection. MR elastography evaluates stiffness with quality checks for wave propagation and measurement reliability. Fat fraction and stiffness describe different tissue properties and are not interchangeable measures of fibrosis or clinical outcome.

When a study includes histopathology, specimen handling and tissue scoring follow a separate pathology workflow. Imaging and tissue results can be reconciled at the study-data level without compromising reader blinding.

Emerging Indication Spotlight: MASH Trials and MRI-PDFF

Metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) has become one of the most active areas of drug development, and noninvasive imaging now plays a central role in screening, enrichment and treatment monitoring. MRI-PDFF quantifies hepatic fat across the whole liver, reducing the sampling limitations of a single biopsy core, while MR elastography adds a measure of liver stiffness relevant to fibrosis staging.

We standardize multi-echo acquisition across scanner vendors and field strengths, define region-of-interest placement and segmentation rules, and qualify sites with test submissions before enrollment. Longitudinal analysis reports absolute and relative fat-fraction change at protocol-defined timepoints, with quality flags for motion, iron overload and other confounding factors. Imaging results are delivered for integration with histology and clinical endpoints as the protocol specifies.

Guidance for Sponsors

Physician-authored guidance from Intrinsic Imaging on imaging endpoints and trial design.

Guidance for Sponsors · Volume 4, Issue 1 · 2026 Edition

Magnetic Resonance Elastography: A Quantitative Endpoint for Liver Fibrosis Trials

Magnetic resonance elastography (MRE) measures liver stiffness without a needle, and it has become one of the most accurate imaging tools available for staging liver fibrosis. Now that the FDA has approved the first therapies for metabolic dysfunction-associated steatohepatitis (MASH), sponsors developing the next generation of liver therapies need endpoints that are quantitative, repeatable and acceptable to patients. Combined with MRI proton density fat fraction (MRI-PDFF) in a single liver MRI exam, MRE provides exactly that: a one-minute acquisition that stages fibrosis and tracks how it changes over the course of a trial.

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Guidance for Sponsors · Volume 5, Issue 1 · 2026 Edition

Immunotherapy and Imaging of Metastatic Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma remains one of the most lethal cancers, with a five-year relative survival of 13% and a rising share of U.S. cancer deaths. After a decade in which checkpoint immunotherapy largely failed in this disease, the therapeutic landscape is finally changing: a new first-line chemotherapy regimen has been approved, and in 2026 an oral RAS inhibitor doubled overall survival in a Phase 3 trial of previously treated patients. These advances raise the stakes for imaging. Contrast-enhanced CT, MRI and FDG-PET/CT must deliver staging and response data that are standardized, reproducible and interpretable under the right criteria, including iRECIST when immunotherapy is involved.

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Illustration of the colon with a red tumor mass in the sigmoid region representing colorectal cancer

Guidance for Sponsors · Volume 6, Issue 8 · 2026 Edition

Metastatic Colorectal Cancer and Locoregional Therapies

The American Cancer Society estimates about 158,850 new cases of colorectal cancer and 55,230 deaths in the United States in 2026, and the disease is now the leading cause of cancer death in adults under 50.[1] Roughly half of patients develop liver metastases, and for most of them the liver is what determines survival. Over the past decade the options for treating those metastases have multiplied: systemic therapy guided by molecular profiling, radioembolization, chemoembolization with drug-eluting beads, thermal ablation and, remarkably, liver transplantation. Each produces imaging changes that conventional size-based criteria handle poorly. This issue reviews the current evidence and what sponsors should build into trials of liver-directed therapy.

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More guidance: Tissue Iron MRI Quantitation in Trials

Browse all Guidance for Sponsors →

Featured Case Study

Gastroenterology & Metabolic

Phase IIb Inflammatory Bowel Disease Trial

Crohn's disease and ulcerative colitis
Endoscopy video, MR enterography
SES-CD and Mayo Endoscopic Score

Challenge

In inflammatory bowel disease trials, endoscopic and cross-sectional assessments of disease activity are inherently interpretive. When scoring is performed at individual sites, that subjectivity translates directly into variability: the same endoscopic finding may be scored differently by different investigators, and eligibility decisions can diverge accordingly. The sponsor needed to reduce this inconsistency from both the screening process and the SES-CD and Mayo Endoscopic Score assessments that anchored the trial's efficacy evaluations.

Read the case study

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More Gastroenterology & Metabolic case studies

Frequently Asked Questions

Does Intrinsic Imaging provide central reading of endoscopy?

Yes. Endoscopy is centrally reviewed alongside CT, MRI and nuclear imaging.

Which gastrointestinal indications does Intrinsic Imaging support?

Our experience includes IBD, ulcerative colitis, GERD, IBS, short bowel syndrome, ulcers and related abdominal and pelvic conditions.

Who reviews gastroenterology trial data?

Gastroenterology data are reviewed by more than 60 board-certified, fellowship-trained gastroenterologists.

Planning a Gastroenterology trial? Reach out!

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