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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05856409
Enrollment
20
Registered
2023-05-12
Start date
2023-05-10
Completion date
2025-12-31
Last updated
2023-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

68Ga-FAPI, PET, ovarian cancer, recurrence detection

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.

Interventions

DIAGNOSTIC_TEST68Ga-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)

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Performance1 yearSensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT
Maximum standardized uptake value(SUVmax)1 yearMeasurement of the maximum standardized uptake value of the lesion
Tumor-to-background ratio (TBR)1 yearTBR was calculated according to the formula:TBR=SUVmax of lesion/SUVmax of background

Secondary

MeasureTime frameDescription
Correlation between FAPI expression and SUV in PET1 yearCorrelation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining of pathological specimen

Countries

China

Contacts

Primary ContactTingting Wang, PH.D
wangtt_shca@126.com15000091930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026