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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI | Diagnostic Test | [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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A prospective cohort of patients with clinically suspected recurrent ovarian cancer were enrolled, who underwent paired 68Ga-FAPI and 18F-FDG PET/CT.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Wang, PH.D | Contact | 15000091930 | wangtt_shca@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianjun Liu, PH.D | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Surgical or biopsy tumor tissue specimens
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |