Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients with Orbital Neoplasms and Compared with 18F-FDG PET/ CT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy
Study 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 orbital neoplasms, and compared with 18F-FDG PET/CT.
Detailed Description
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of metastatic 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include MRI, CT 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 pregnancy;
- •breastfeeding;
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Arms & Interventions
Experimental arm
Experimental arm
Intervention: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT (Diagnostic Test)
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: through study completion, an average of 6 months
The diagnostic accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Secondary Outcomes
- SUV metrics(through study completion, an average of 6 months)
- Tumor-to-background ratio(through study completion, an average of 6 months)
- Number of lesions(through study completion, an average of 6 months)