Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer

January 20, 2024 updated by: Feng-Yuan Liu, MD, Chang Gung Memorial Hospital

Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer With CA125 Elevation From Complete Response After Therapy

A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan
        • Recruiting
        • Chang-Gung Memorial Hospital, LinKou Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically proven ovarian cancer with complete response after therapy
  • Age between 30 and 80
  • Elevation of serum CA125 value above the normal range (>35 U/mL) or doubling of serum CA125 value within the normal range
  • ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
  • Willing to enter this prospective study with signed informed consent form

Exclusion Criteria:

  • Patients with history of other malignancy
  • Patients who are pregnant or lactating
  • Patients with fasting fingerstick glucose level higher than 200 mg/dl
  • Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
  • Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-FAPI ,PET/CT
Inject 68Ga-FAPI and then perform PET/CT scan.
Diagnostic test: 68Ga-FAPI-46
Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46
Other Names:
  • 68Ga-fibroblast activating protein inhibitors
Diagnostic test: 18F-FDG
Intravenous injection of one dosage of 5-10mCi 18F-FDG
Other Names:
  • 18F-fluorodeoxyglucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
Time Frame: 2 months for individual participants to complete all visits

Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4).

Cancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study.
2 months for individual participants to complete all visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 5 years
Progression-free survival (PFS) is defined as the duration (months) from the initiation of further therapy to disease progression assessed by Gynecological Cancer Intergroup (GCIG) guideline which incorporates both RECIST 1.1 and CA125 or to death.
5 years
Overall Survival (OS)
Time Frame: 5 years
Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

January 20, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202102208A0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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