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

Chang Gung Memorial Hospital45 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

68Ga-FAPI-46DIAGNOSTIC_TEST

Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46

18F-FDGDIAGNOSTIC_TEST

Intravenous injection of one dosage of 5-10mCi 18F-FDG

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Chang-Gung Memorial Hospital, Linkou Branch

Taoyuan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: 2 months for individual participants to complete all visits

Secondary Outcomes

Progression-free survival (PFS)

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.

Time frame: 5 years

Overall Survival (OS)

Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death.

Time frame: 5 years

Central Contacts

Feng-Yuan Liu

CONTACT

0975365782 billliu@cgmh.org.tw

Data from ClinicalTrials.gov

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