Evaluating the Usefulness of 18F-AlF-FAPI PET/ CT in Orbital Neoplasms

Not Applicable

Recruiting

• Conditions: Orbital Neoplasms

• Registration Number: NCT06791226
• Lead Sponsor: Peking University Third Hospital

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 Timeline

• Study First Submitted: 2024-04-07
• Study Start: 2024-07-16
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dept. of Nuclear Medicine, Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China