What this trial means for you
This study is recruiting now at 1 US site. It's studying Radiotracer Injection, Contrast Media, Magnetic Resonance, Glucagon, Oral contrast media application for crohn disease.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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).
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * Age greater than 18 years * Biopsy confirmed/suspected Crohn's disease * Ability to give written informed consent Exclusion Criteria: * 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);
Study sites by state
Massachusetts
- Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School — Charlestown · Recruiting now
View the official record on ClinicalTrials.gov →
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