18F-FAPI PET to detect intestinal lesions and measure IBD activity
Evaluation of Intestinal Lesions and Disease Activity in Inflammatory Bowel Disease Based on 18F-FAPI PET Imaging
This project will test whether 18F-FAPI PET scans can detect intestinal lesions and measure disease activity in adults with inflammatory bowel disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06945549 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with a confirmed diagnosis of IBD who undergo 18F-FAPI PET/CT, colonoscopy, and enhanced abdominal CT within one week so imaging and endoscopic findings can be directly compared. Investigators will match intestinal segments across modalities to determine how well FAPI PET identifies lesions and correlates with clinical disease activity. Poor-quality images and contraindications to endoscopy or CT are exclusion criteria. Participants will be followed for 12 months for major adverse outcomes to explore whether baseline imaging predicts clinical course.
Who should consider this trial
Good fit: Adults (≥18 years) with a documented diagnosis of inflammatory bowel disease who can undergo PET/CT, colonoscopy, and enhanced abdominal CT within one week and who consent to 12-month follow-up.
Not a fit: Pregnant or lactating individuals, patients with unusable imaging quality, and those who cannot safely undergo endoscopy or CT are excluded and unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, FAPI PET could provide a less invasive and potentially more sensitive way to locate intestinal lesions and monitor disease activity, which might reduce the need for repeated colonoscopies.
How similar studies have performed: Early pilot and small cohort studies of FAPI PET in inflammatory and fibrotic conditions have shown promising lesion localization, but large-scale validation specifically in IBD remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria; * Patients ≥18 years old; * 18F-FAPI PET/CT intestinal imaging, conventional endoscopic and enhanced CT were performed within 1 week; * Intestinal segment matching was evaluated by endoscopy and imaging; * Patients voluntarily participate and sign informed consent. Exclusion Criteria: * Pregnant or lactating patients; * Imaging images are of poor quality and cannot be used for diagnosis and evaluation; * Patients with contraindications for endoscopic or CT examination.
Where this trial is running
Chongqing, Chongqing Municipality
- Army Medical Center of PLA, Daping Hospital, Army Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wenbo Li, postgraduate
- Email: lwb@tmmu.edu.cn
- Phone: +8615292886778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.