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

Last updated: August 6, 2020
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT04504110
FAPIEOC
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent signed

  • EOC patients who are scheduled for surgery. The diagnosis of EOC should be based onthe previous histological results or cytological evaluation combined with a serumCA-125 to carcinoembryonic antigen ratio＞25 to confirm the primary diagnosis andexclude a nongynecologic cancer.

Exclusion

Exclusion Criteria:

  • 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. adjuvantchemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy.

  • Pregnant or breast-feeding women.

  • Any mental condition rendering the patient unable to understand the nature, scope, andpossible consequences of the study, and/or evidence of an uncooperative attitude.

Study Design

Total Participants: 30
Study Start date:
August 05, 2020
Estimated Completion Date:
August 31, 2021

Study Description

Patients with epithelial ovarian cancer who are scheduled for surgical intervention will be recruited in this study. They will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery. No tumor-specific treatment is allowed between the scan and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. Three types of lesions will be marked based on 68Ga-FAPI-04 and 18F-FDG PET/CT findings, which is FAPI+/FDG-, FAPI-/FAPI+, and FAPI+/FDG+ lesions. The marked lesions will be explored by the surgeon, resected if possible, and compared with histological results. A fourth type of lesion will be added into the analysis if that lesion is both FAPI and FAP negative but is a histological-confirmed positive lesion.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.