Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- The First Affiliated Hospital of Xiamen University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.
Detailed Description
Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients (aged 18 years or order);
- •patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- •patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
- •patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria
- •patients with non-malignant lesions;
- •patients with pregnancy;
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: 30 days
The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Secondary Outcomes
- SUV(7 days)
- Number of lesions(7 days)