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

Not Applicable

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Diagnostic Test: 68Ga-FAPI-46; Diagnostic Test: 18F-FDG

• Registration Number: NCT06232122
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-20
• Last Update Submitted: 2024-01-20
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI ,PET/CT	18F-FDG	Inject 68Ga-FAPI and then perform PET/CT scan.
68Ga-FAPI ,PET/CT	68Ga-FAPI-46	Inject 68Ga-FAPI and then perform PET/CT scan.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	5 years	Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death.
Progression-free survival (PFS)	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.

Trial Locations

Locations (1)

Chang-Gung Memorial Hospital, Linkou Branch; 🇨🇳 Taoyuan City, Taiwan