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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04502303
• Other study ID #: FAPICD
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Peking Union Medical College Hospital
• Contact: Wenjia Zhu, MD
• Phone: +86 18614080164
• Email: zhuwenjia_pumc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Histological findings	In patients with surgical resection of stenotic intestine, the extent of inflammation and fibrosis will be determined.	Day 90 after surgery