Orbital Neoplasms
Conditions
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.
Interventions
DIAGNOSTIC_TEST18F-AlF-FAPI PET/CT, 18F-FDG PET/CT
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for diagnosis and staging.
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include MRI, CT and pathology report); 2. patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans; 3. 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
1. patients with pregnancy; 2. breastfeeding; 3. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 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
| Measure | Time frame | Description |
|---|---|---|
| SUV metrics | through study completion, an average of 6 months | Standardized uptake value (SUV) metrics of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. |
| Tumor-to-background ratio | through study completion, an average of 6 months | tumor-to-background ratio of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. |
| Number of lesions | through study completion, an average of 6 months | The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. |
Countries
China
Contacts
Primary ContactHui Li
Backup ContactLingge Suo
Outcome results
None listed