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Clinical Trials/NCT05856409
NCT05856409
Recruiting
Not Applicable

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

RenJi Hospital1 site in 1 country20 target enrollmentMay 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
68Ga-FAPI
Sponsor
RenJi Hospital
Enrollment
20
Locations
1
Primary Endpoint
Tumor-to-background ratio (TBR)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Tumor-to-background ratio (TBR)

Time Frame: 1 year

TBR was calculated according to the formula:TBR=SUVmax of lesion/SUVmax of background

Diagnostic Performance

Time Frame: 1 year

Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT

Maximum standardized uptake value(SUVmax)

Time Frame: 1 year

Measurement of the maximum standardized uptake value of the lesion

Secondary Outcomes

  • Correlation between FAPI expression and SUV in PET(1 year)

Study Sites (1)

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