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NCT06252493Recruiting

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

Evaluation of PET/MR Enterography for Differentiation of Fibrotic and Inflammatory Strictures in Patients With Crohn's Disease Using a Collagen-binding Radiotracer.
Massachusetts General HospitalClinicalTrials.govdrug
Study focus
Disease/Condition
Crohn Disease
Drug/Device/Intervention
Radiotracer Injection
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
Massachusetts General Hospital
Location
Charlestown, United States of America
Timeline & enrollment
Phase
N/A
Start date
Dec 19, 2023
End date
Dec 19, 2025
Enrollment
25 participants
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
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease of small intestineCrohn disease [regional enteritis]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06252493
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.