Evaluating the Usefulness of 18F-AlF-FAPI PET/ CT in Orbital Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT.
- Who it may be relevant to
- Registry conditions: Orbital Neoplasms. Basic parameters: 3 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients With Orbital Neoplasms and Compared With 18F-FDG PET/ CT
Overview
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 test 18F-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.
Primary outcome measures
- Diagnostic accuracy [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (3)
- SUV metrics [Time frame: through study completion, an average of 6 months]
- Tumor-to-background ratio [Time frame: through study completion, an average of 6 months]
- Number of lesions [Time frame: through study completion, an average of 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Dept. of Nuclear Medicine, Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06791226 · FAPI-Orbital Neoplasms