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

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

NCT ID: NCT05856409

Condition: 68Ga-FAPI
Ovarian Cancer
Epithelial Ovarian Cancer
Positron Emission Tomography

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence

Conditions: Keywords:
68Ga-FAPI
PET
ovarian cancer
recurrence detection

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: 68Ga-FAPI
Description: [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)

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.

Criteria for eligibility:

Study pop:
A prospective cohort of patients with clinically suspected recurrent ovarian cancer were enrolled, who underwent paired 68Ga-FAPI and 18F-FDG PET/CT.

Sampling method: Non-Probability Sample
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

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Locations:

Facility:
Name: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Address:
City: Shanghai
Zip: 200127
Country: China

Status: Recruiting

Contact:
Last name: Jianjun Liu, PH.D

Phone: +86 13301826638
Email: nuclearj@163.com

Start date: May 10, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: RenJi Hospital
Agency class: Other

Source: RenJi Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05856409