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NCT05856409 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05856409
Other study ID # LY2023-024-B
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date December 31, 2025

Study information
Verified date August 2023
Source RenJi Hospital
Contact Tingting Wang, PH.D
Phone 15000091930
Email wangtt_shca@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date April 1, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 68Ga-FAPI
[68Ga]-FAPI is tumor imaging agent for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF)

Locations
Country Name City State
China Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic Performance Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT 1 year
Primary Maximum standardized uptake value(SUVmax) Measurement of the maximum standardized uptake value of the lesion 1 year
Primary Tumor-to-background ratio (TBR) TBR was calculated according to the formula:TBR=SUVmax of lesion/SUVmax of background 1 year
Secondary Correlation between FAPI expression and SUV in PET Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining of pathological specimen 1 year
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