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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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68Ga-FAPI, Ovarian Cancer, Epithelial Ovarian Cancer, Positron Emission Tomography

Intervention / Treatment
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* Diagnostic Test: 68Ga-FAPI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-FAPI, PET, ovarian cancer, recurrence detection