Inflammatory Bowel Disease Clinical Trial
Official title:
Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of inflammatory bowel disease than 18F-FDG PET/CT.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - suspected or confirmed untreated inflammatory bowel disease patients; - 18F-FDG PET/CT within two weeks; - signed written consent. Exclusion Criteria: - pregnancy; - breastfeeding; - known allergy against FAPI - any medical condition that in the opinion of the investigator may significantly interfere with study compliance. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic value | Sensitivity and Specificity of 68Ga-FAPI PET/CT for inflammatory bowel disease in comparison with 18F-FDG PET/CT | through study completion, an average of 1 year | |
Secondary | Metabolic parameters | Total Lesion Glycolysis (TLG) of bowel lesions are measured on 68Ga-FAPI PET/CT. | through study completion, an average of 1 year | |
Secondary | FAPI expression and SUV | Correlation between FAPI expression and SUV in PET | through study completion, an average of 1 year | |
Secondary | Disease burden assessement | Correlation between Total Lesion Glycolysis (TLG) of bowel lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for inflammatory bowel disease | through study completion, an average of 1 year | |
Secondary | therapy response | Decrease of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy | through study completion, an average of 1 year |
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