18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT04502303|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consecutive days.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Crohn's disease: patients with intestinal stricture
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
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.
- SUVmax of stenotic intestine [ Time Frame: Day 30 after PET scan ]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.
- MV of stenotic intestine [ Time Frame: Day 30 after PET scan ]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.
- TMI of stenotic intestine [ Time Frame: Day 30 after PET scan ]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.
- Histological findings [ Time Frame: Day 90 after surgery ]In patients with surgical resection of stenotic intestine, the extent of inflammation and fibrosis will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502303
|Contact: Wenjia Zhu, MD||+86 firstname.lastname@example.org|
|Contact: Li Huo, MD||+86 email@example.com|