18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease

Study Overview
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Brief Summary
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Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the result of chronic transmural inflammation combined with a dysregulated wound-healing process. While inflammatory strictures may respond to anti-inflammatory treatment, fibrotic strictures are usually anti-inflammation resistant, requiring further endoscopic balloon dilation or surgical intervention. Therefore, to determinate the inflammatory or fibrotic nature of intestinal stricture is a key step in the treatment of CD. 18F-FDG is a radiotracer reflecting the glucose metabolism of disease and is usually accumulated in inflammatory disease. 68Ga-FAPI is a novel radiotracer that specifically targets fibroblast activation protein (FAP). FAP is a membrane glycoprotein expressed on activated fibroblasts, which are key cells in the process of fibrotic intestinal stricture of CD. In this study, we hypothesis that the inflammatory or fibrotic nature of intestinal stricture can be non-invasively evaluated by 18F-FDG and 68Ga-FAPI PET/CT in patients with CD.

Detailed Description
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Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consectutive days. The accumulation of 18F-FDG and 68Ga-FAPI at the site of stricture will be determined by standard uptake value (SUV), molecular volume (MV), and total molecular index (TMI). In patients with a planned surgical resection of one or more stricture (s), the image results will be compared with histological findings.

Official Title
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A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT

Conditions
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Crohn Disease

Intervention / Treatment
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* Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed Crohn's disease patients with proofs of intestine stricture by other modalities, e.g. MRI, CT, ultrasound, and/or endoscopy. Exclusion Criteria: Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. Pregnant or breast-feeding women. Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consecutive days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crohn's disease: patients with intestinal stricture<br>Patients with intestinal strictures confirmed by other modalities, e.g. CT, MR, ultrasound, and endoscopy, will be recruited in the study. | Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT<br>* Participants will undergo 18F-FDG (0.12-0.15mCi/kg) and 68Ga-FAPI (3-6mCi) PET/CT on two consecutive days. At least 6 hours of fast is required for 18F-FDG PET scan, while no dietary control is necessary for 68Ga-FAPI PET scan. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. If the patient is planned for surgical resection of one or more stricture (s), the scans have to be completed within a maximum period of 30 days before the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax of stenotic intestine | The SUVmax of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the highest extent of inflammation and fibrosis, respectively. | Day 30 after PET scan | 
| MV of stenotic intestine | The MV of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the involved area of inflammation and fibrosis, respectively. | Day 30 after PET scan | 
| TMI of stenotic intestine | The TMI of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the overall extent of inflammation and fibrosis, respectively. | Day 30 after PET scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological findings | In patients with surgical resection of stenotic intestine, the extent of inflammation and fibrosis will be determined. | Day 90 after surgery |