Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06791226

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Orbital Neoplasms Bone Diseases Bone Neoplasms Eye Diseases Eye Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Orbital Diseases Skull Neoplasms

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-AlF-FAPI PET/CT, 18F-FDG PET/CT

Diagnostic Test

Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for diagnosis and staging.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Li

CONTACT

[email protected]

86-010-82264935

Lingge Suo

CONTACT

[email protected]

86-010-82264935

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.