Clinical Trial · NCT04504110

68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings

Overview

Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with epithelial ovarian cancer who are scheduled for surgical intervention. The findings of 68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in evaluating EOC, and histological findings.

Sponsor

Peking Union Medical College Hospital

Phase

Phase 2

Contacts

Wenjia Zhu, MD (CONTACT)

zhuwenjia_pumc@163.com

+86 18614080164

Li Huo, MD (CONTACT)

zhuwenjia_pumc@163.com

+86 13910801986

ClinicalTrials.gov

NCT04504110

Drug / Compound

FDG

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

FAPI-04

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

EOC patients who are scheduled for surgery. The diagnosis of EOC should be based on the previous histological results or cytological evaluation combined with a serum CA-125 to carcinoembryonic antigen ratio\>25 to confirm the primary diagnosis and exclude a nongynecologic cancer.

Exclusion

Pregnant or breast-feeding women.
Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI-04.
Tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy.
Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.