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Observational Study of PET/MR Enterography for Crohn's Disease

This study is looking at a new way to identify and understand strictures (narrowing of the intestine) in people with Crohn's disease. Researchers will use a special imaging technique called PET/MR enterography, which combines two types of scans, along with an injected substance called [68Ga]CBP8 (a radiotracer that helps highlight certain areas). They will also use Dotarem, a contrast dye, and Glucagon to help with imaging. Blood will be drawn to check for markers of scarring. The goal is to see how well this imaging method can detect fibrotic (scarred) strictures before surgery. You may be able to join if you are over 18, have confirmed or suspected Crohn's disease, and are scheduled for possible surgery. The study aims to enroll 25 participants. The study status is unclear.

Study design
This is an observational study, meaning participants will undergo specific tests but will not receive an experimental treatment. It aims to enroll 25 participants.
What's involved
You would have an intravenous catheter (IV) placed for injections of [68Ga]CBP8, Dotarem, and Glucagon, and for blood draws. You would also undergo PET/MR imaging of your abdomen and pelvis.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, detection rate of fibrotic strictures, will be measured from the date of the PET/MRE examination to the date of final histopathology results (1-2 months).

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NCT06252493

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

Recruiting
Not specifiedAges 18–99Observational
Massachusetts General Hospital
~25 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Radiotracer InjectionContrast Media, Magnetic ResonanceBlood DrawGlucagonImagingOral contrast media application

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection Rate of Fibrotic Strictures with [68Ga]CBP8-PET PET/MRE.
Measured over From date of PET/MRE examination to date of final Histopathology result (1-2 Months)

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Onofrio Catalano, MD, Ph.D · PRINCIPAL_INVESTIGATOR · Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Who to contact

Onofrio Catalano, MD, Ph.D
[email protected]
617-724-4030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Electrical implants such as cardiac pacemaker or perfusion pump;
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;
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);
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;
Research-related radiation exposure exceeds current Radiation Safety Committee guidelines (i.e. 50 mSv in the prior 12 months);
BMI \> 33 (limit of the PET/MR table);
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.)
Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);

What this trial measures

  • Detection Rate of Fibrotic Strictures with [68Ga]CBP8-PET PET/MRE.From date of PET/MRE examination to date of final Histopathology result (1-2 Months)

    The primary endpoint of the study is to evaluate the performance of PET/MRE using \[68Ga\]CBP8- PET in detecting strictures containing a fibrotic component. This performance will also be compared with that of PET alone and MR enterography alone that will be acquired during the scan as well as to the findings noted at the time of surgical intervention and/or upon histologic analysis, when possible.