NCT04504110

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 5, 2020

Last Update Submit

August 6, 2020

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • SUVmax of positive lesions

    68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax

    1 hour after tracer injection

Secondary Outcomes (1)

  • Histological findings

    60 day after surgery

Study Arms (1)

Epithelial ovarian cancer

EXPERIMENTAL

68Ga-FAPI-04 and 18F-FDG PET/CT

Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

Interventions

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CTDIAGNOSTIC_TEST

Patients with epithelial ovarian cancer who are scheduled for surgical intervention will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery.

Epithelial ovarian cancer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOvarian cancer is a female-specific tumor entity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent signed
  • 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.

You may not qualify if:

  • 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.
  • Pregnant or breast-feeding women.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Wenjia Zhu, MD

CONTACT

+86 18614080164zhuwenjia_pumc@163.com

Li Huo, MD

CONTACT

+86 13910801986zhuwenjia_pumc@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

August 5, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)