Non-invasive imaging for diagnosing intestinal fibrosis in Crohn's disease
A Non-invasive Diagnostic Model for Intestinal Fibrosis in Crohn's Disease Based on 18F-FAPI PET Imaging
This study is testing a new way to use special imaging to help doctors find and understand intestinal scarring in adults with Crohn's disease without needing surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (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) |
| Trial ID | NCT05824962 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a non-invasive diagnostic model for assessing intestinal fibrosis in patients with Crohn's disease using 18F-FAPI PET imaging. It involves a prospective, multicenter approach where adult patients diagnosed with Crohn's disease will undergo various imaging techniques, including PET/CT and computed-tomography enterography (CTE), to evaluate the severity of intestinal fibrosis. Clinical data will be collected, including disease history and imaging results, to correlate with pathological findings post-surgery. The study seeks to improve early detection of fibrosis, which is crucial for determining appropriate treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with Crohn's disease and are scheduled for surgical resection of intestinal segments.
Not a fit: Patients who are pregnant, lactating, or have contraindications for imaging examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable non-invasive method for early detection of intestinal fibrosis, leading to better treatment outcomes for patients with Crohn's disease.
How similar studies have performed: While the use of imaging techniques for assessing intestinal fibrosis is established, the specific application of 18F-FAPI PET imaging in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with CD based on clinical, imaging, endoscopic, and histopathological criteria; 2. Patient age ≥ 18 years old; 3. Within 15 days before surgery, 18F-FAPI, 18F-FDG PET/CT intestinal imaging, and routine CTE imaging were performed; 4. Surgical resection of intestinal segments and imaging evaluation of intestinal segment matching; 5. The pathological analysis of surgical specimens includes H\&E, Masson, GLUT1 and FAP immunohistochemical staining; 6. The patient voluntarily participates and signs an informed consent form. Exclusion Criteria: 1. Pregnant or lactating patients; 2. The quality of imaging images is poor and cannot be used for diagnosis and evaluation; 3. If the pathological section of the specimen does not cover the entire intestinal wall; 4. The fasting blood glucose level is higher than 11.1mmol/L; 5. Patients with contraindications for CTE examination.
Where this trial is running
Chongqing, Chongqing
- Department of Nuclear Medicine, Daping Hospital of Army Medical University — Chongqing, Chongqing, China (Recruiting)
Study contacts
- Principal investigator: Xiao Chen, Ph.D — Daping Hospital, Army Medical University
- Study coordinator: Xiao Chen, Ph.D
- Email: xiaochen229@foxmail.com
- Phone: 15922970174
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.