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NCT07273188 · ClinicalTrials.gov registry record · Early Phase 1
68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
A Early Phase 1 study of Crohn's Disease and Intestinal Fibrosis, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT07273188 is a Early Phase 1 study of Crohn's Disease and Intestinal Fibrosis that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 45 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07273188, a Early Phase 1 study of Crohn's Disease and Intestinal Fibrosis, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. The goal is to determine whether areas of early or developing fibrosis ("pre-stricture" changes) demonstrate uptake of the tracer, which binds to fibroblast activation protein (FAP). Participants with small bowel Crohn's disease will be assigned to either a case or control group based on CT or MR enterography findings at enrollment. Cases will include participants who have a small bowel stricture or probable stricture, with or without penetrating complications. Controls will include participants with small bowel Crohn's disease without strictures. Controls may have active inflammatory disease, luminal narrowing, or no active inflammation (including postoperative or chronic changes), as long as no stricture is present. Because most radiologic strictures represent more advanced fibrostenosis, the study aims to enroll a larger proportion of controls to better characterize early fibrotic changes. Approximately one-third to one-half of participants will be cases, and the remainder controls. This design will allow comparison of FAPI uptake patterns in patients with and without strictures to understand how FAP expression relates to the development of small bowel fibrosis.
Conditions Studied
Interventions
- DRUG Ga68-FAPI-46
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2026-01-26 |
| Est. Completion | 2027-04-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07273188
The ClinicalTrials.gov registry entry for NCT07273188 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Ga68-FAPI-46 is the first listed.
NCT07273188 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT07273188 about?
NCT07273188 is a clinical study titled "68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease". This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. The goal is to determine whether areas of early or developing fibrosis ("pre-stricture" changes) demonstrate uptake of the tracer, which b...
What is the current status of trial NCT07273188?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2026-01-26. Estimated completion is 2027-04-30.
What conditions does trial NCT07273188 study?
This clinical trial studies the following conditions: Crohn's Disease, Intestinal Fibrosis, Inflamatory Bowel Disease, Intestinal Strictures Related to Crohn´s Disease.
What interventions are being tested in trial NCT07273188?
The interventions under investigation include: Ga68-FAPI-46 (DRUG).
Who is sponsoring clinical trial NCT07273188?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07273188 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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