Evaluating the Usefulness of 18F-AlF-FAPI PET/ CT in Orbital Neoplasms
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients With Orbital Neoplasms and Compared With 18F-FDG PET/ CT
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2024
CompletedStudy Start
First participant enrolled
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
January 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 24, 2025
January 1, 2025
4.5 years
April 7, 2024
January 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy
The diagnostic accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
through study completion, an average of 6 months
Secondary Outcomes (3)
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
Study Arms (1)
Experimental arm
EXPERIMENTALExperimental arm
Interventions
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for diagnosis and staging.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- patients with pregnancy;
- breastfeeding;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Nuclear Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2024
First Posted
January 24, 2025
Study Start
July 16, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share