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

P

Peking University

Status

Enrolling

Conditions

Orbital Neoplasms

Treatments

Diagnostic Test: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT06791226
FAPI-Orbital Neoplasms

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

3 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Experimental arm
Experimental group
Description:
Experimental arm
Treatment:
Diagnostic Test: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT

Trial contacts and locations

1

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Central trial contact

Lingge Suo; Hui Li

Data sourced from clinicaltrials.gov

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