NCT06252493Recruiting

Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.

Evaluation of PET/MR Enterography for Differentiation of Fibrotic and Inflammatory Strictures in Patients With Crohn's Disease Using a Collagen-binding Radiotracer.

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

In this study twenty-five (25) subjects with Crohn's disease scheduled for possible surgical intervention will be recruited for this study and a PET/MR scan using the collagen-binding radiotracer will be performed. The study aims to establish the performance figures of PET/MR using \[68Ga\]CBP8-PET for preoperative detection and differentiation of strictures with a fibrotic component in patients with Crohn's disease by using surgical and histologic findings (when available) as the standard for comparison. Furthermore, the investigators will determine the performance figures with which strictures are identified and characterized by PET/MR using \[68Ga\]CBP8-PET compared to each modality in isolation (PET alone or MR alone). Blood and tissue markers for fibrostenosis will be explored (either predictive or as biomarkers for fibrotic burden), using histologic and molecular testing by using surgical and histologic findings (when available) as the standard for comparison. Lastly the investigators want to determine the performance figures with which strictures are identified and characterized by PET/MR using \[68Ga\]CBP8-PET compared to each modality in isolation (PET alone or MR alone).

Status (registry): Recruiting
Study type: Observational
Enrollment: 25 (estimated)
First submitted: 2 Feb 2024
Start date: 19 Dec 2023
Primary completion date: 19 Dec 2027
Lead sponsor: Massachusetts General Hospital
Diseases: Crohn's disease
NCT number: NCT06252493

What you commit to

Study type: Observational
Planned participants: 25
From 19 Dec 2023 to the primary completion date, 19 Dec 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
Research-related radiation exposure exceeds current Radiation Safety Committee guidelines (i.e. 50 mSv in the prior 12 months);

Other illness

Electrical implants such as cardiac pacemaker or perfusion pump;
History of claustrophobia or any other condition considered likely to preclude the patient from lying comfortably in the MR/PET scanner for the duration of the exam;
Co-morbid conditions known to cause fibrosis that may interfere with the results of the exam (e.g., retroperitoneal fibrosis, mesenteric panniculitis, desmoid tumor etc.)

Lab values

eGFR of less than 30 mL/min/1.73 m2 within the past 90 days;
Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test will be required for females of child-bearing age before the subject can participate);

Other

BMI \> 33 (limit of the PET/MR table);
Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);

Who the study is looking for

Age greater than 18 years
Biopsy confirmed/suspected Crohn's disease
Ability to give written informed consent

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School Coordinator of this site? Confirm its status	Charlestown	United States	Recruiting

Related publications

Collagen-binding probe PET/MR for distinguishing fibrotic from inflammatory strictures in Crohn's disease.Eur J Nucl Med Mol Imaging · 2026 · PMID 41699282

This page is information, not medical advice. Discuss any trial with your doctor.