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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Diagnostic Test: 18F-FDG; Diagnostic Test: 68Ga-FAPI-46

Study type: Interventional

Funder types: Other

Identifiers

NCT06232122

202102208A0

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

68Ga-FAPI ,PET/CT

Experimental group

Description:

Inject 68Ga-FAPI and then perform PET/CT scan.

Treatment:

Diagnostic Test: 68Ga-FAPI-46

Diagnostic Test: 18F-FDG