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

Primary Purpose

Epithelial Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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. 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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epithelial ovarian cancer

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Histological findings
The presence of tumor cells on resected specimen will be evaluated by pathologists. The FAP expression will be determined using immunohistochemical staining using anti-FAP antibody (Abcam).

Full Information

First Posted
August 5, 2020
Last Updated
August 6, 2020
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04504110
Brief Title
68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
Official Title
A Prospective Study to Evaluate 68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epithelial ovarian cancer
Arm Type
Experimental
Arm Description
68Ga-FAPI-04 and 18F-FDG PET/CT
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
SUVmax of positive lesions
Description
68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax
Time Frame
1 hour after tracer injection
Secondary Outcome Measure Information:
Title
Histological findings
Description
The presence of tumor cells on resected specimen will be evaluated by pathologists. The FAP expression will be determined using immunohistochemical staining using anti-FAP antibody (Abcam).
Time Frame
60 day after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Ovarian cancer is a female-specific tumor entity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjia Zhu, MD
Phone
+86 18614080164
Email
zhuwenjia_pumc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, MD
Phone
+86 13910801986
Email
zhuwenjia_pumc@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yupei Zhao, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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