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NCT06252493 · ClinicalTrials.gov registry record
Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
A clinical trial of Crohn Disease, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 25
- Enrollment target
- 1
- Study location
NCT06252493: Recruiting study of Crohn Disease, sponsored by Massachusetts General Hospital.
NCT06252493 is a study of Crohn Disease that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 25 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06252493, a study of Crohn Disease, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 25 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
The primary endpoint of the study is to evaluate the performance of PET/MRE using \[68Ga\]CBP8- PET in detecting strictures containing a fibrotic component. This performance will also be compared with that of PET alone and MR enterography alone that will be acquired during the scan as well as to the findings noted at the time of surgical intervention and/or upon histologic analysis, when possible.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood Draw
- DRUG Radiotracer Injection
- DIAGNOSTIC_TEST Imaging
- DRUG Contrast Media, Magnetic Resonance
- DRUG Glucagon
Study Locations (1)
Massachusetts
- Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-12-19 |
| Est. Completion | 2029-12-19 |
What NCT06252493 shows while recruiting
NCT06252493 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 5 interventions - of which Blood Draw is the first listed.
NCT06252493 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06252493 about?
NCT06252493 is a clinical study titled "Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.". 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 ...
What is the current status of trial NCT06252493?
This trial is currently recruiting. The enrollment target is 25 participants. The study started on 2023-12-19. Estimated completion is 2029-12-19.
What conditions does trial NCT06252493 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT06252493?
The interventions under investigation include: Blood Draw (DIAGNOSTIC_TEST), Radiotracer Injection (DRUG), Imaging (DIAGNOSTIC_TEST), Contrast Media, Magnetic Resonance (DRUG), Glucagon (DRUG).
Who is sponsoring clinical trial NCT06252493?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06252493 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06252493's enrollment target sits among peer trials
25 57th of 71 higher than 14 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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