Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer. - Trial NCT06252493
Access comprehensive clinical trial information for NCT06252493 through Pure Global AI's free database. This phase not specified trial is sponsored by Massachusetts General Hospital and is currently Recruiting. The study focuses on Crohn Disease. Target enrollment is 25 participants.
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Study Focus
Sponsor & Location
Massachusetts General Hospital
Timeline & Enrollment
N/A
Dec 19, 2023
Dec 19, 2025
Primary Outcome
Detection Rate of Fibrotic Strictures with [68Ga]CBP8-PET PET/MRE.
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06252493
Non-Device Trial