Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence

Recruiting

• Conditions: Epithelial Ovarian Cancer; Positron Emission Tomography; 68Ga-FAPI; Ovarian Cancer

• Registration Number: NCT05856409
• Lead Sponsor: RenJi Hospital

Brief Summary

This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.

Detailed Description

Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-05-03
• Study Start: 2023-05-10
• Study First Posted: 2023-05-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-04-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• adult patients (age>18 and<80 years)
• patients with clinically suspected recurrent ovarian cancer
• patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week
• patients who did not receive any other treatment 4 weeks before PET imaging

Exclusion Criteria

• pregnant patients
• patients with poor performance status
• patients unwilling to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor-to-background ratio (TBR)	1 year	TBR was calculated according to the formula：TBR=SUVmax of lesion/SUVmax of background
Diagnostic Performance	1 year	Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT
Maximum standardized uptake value（SUVmax）	1 year	Measurement of the maximum standardized uptake value of the lesion

Secondary Outcome Measures

Name	Time	Method
Correlation between FAPI expression and SUV in PET	1 year	Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining of pathological specimen

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China