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

January 19, 2025 updated by: Peking University Third Hospital

Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients with Orbital Neoplasms and Compared with 18F-FDG PET/ CT

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Dept. of Nuclear Medicine, Peking University Third Hospital
        • Contact:
        • Contact:
        • Contact:
          • Hui Li, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV metrics
Time Frame: 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.
through study completion, an average of 6 months
Tumor-to-background ratio
Time Frame: 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.
through study completion, an average of 6 months
Number of lesions
Time Frame: 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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPI-Orbital Neoplasms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orbital Neoplasms

Clinical Trials on 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe