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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Age greater than 18 years

• Biopsy confirmed/suspected Crohn's disease

• Ability to give written informed consent

Locations
United States
Massachusetts
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
RECRUITING
Charlestown
Contact Information
Primary
Onofrio Catalano, MD, Ph.D
ocatalano@mgh.harvard.edu
617-724-4030
Backup
Diandrea Galloway
dgalloway@mgh.harvard.edu
617-643-1407
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2025-12-19
Participants
Target number of participants: 25
Treatments
Crohn Disease
Patients with confirmed/suspected Crohn's disease scheduled for operative management/surgical intervention
Related Therapeutic Areas
Sponsors
Collaborators: Takeda Development Center Americas, Inc.
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov