Actively Recruiting
Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
Led by Massachusetts General Hospital · Updated on 2026-03-12
25
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Biopsy confirmed or suspected Crohn's disease
- Ability to give written informed consent
You will not qualify if you...
- Presence of electrical implants such as cardiac pacemaker or perfusion pump
- Presence of 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
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 within the past 90 days
- Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test required for females of child-bearing age before participation)
- History of claustrophobia or any condition likely to prevent lying comfortably in the MR/PET scanner for the exam duration
- Research-related radiation exposure exceeding 50 mSv in the past 12 months
- Body mass index (BMI) greater than 33 (limit of the PET/MR table)
- Co-morbid conditions causing fibrosis that may interfere with exam results (e.g., retroperitoneal fibrosis, mesenteric panniculitis, desmoid tumor)
- Determined clinically unsuitable for the study by the investigator(s)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
Research Team
O
Onofrio Catalano, MD, Ph.D
CONTACT
D
Diandrea Galloway
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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