18F-FAPI PET in Cancers of Unknown Primary Site

Zhejiang University

Status: Not yet enrolling

Conditions: Cancer of Unknown Primary Site

Treatments: Diagnostic Test: 18F-FAPI PET

Study type: Observational

Funder types: Other

Identifiers

NCT07372963

FirstZhejiangU-FAPI-CUPs

Details and patient eligibility

About

This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.

Full description

Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy).

secondary end points:

• The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared.

  ④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen).

• Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with clinical or imaging suspicion of cancer of unknown primary origin.
2. Patients with 18F FAPI PET scans.

Exclusion criteria

1. Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
2. Severe uncontrollable diseases or active infections;
3. Ineligible participants for project informed consent.
4. Pregnant and lactating women.

Trial design

120 participants in 1 patient group

FAPI-cups

Description:

FAPI PET scan in patients with CUPs

Treatment:

Diagnostic Test: 18F-FAPI PET