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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232122
• Other study ID #: 202102208A0
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 31, 2028

Study information

• Verified date: January 2024
• Source: Chang Gung Memorial Hospital
• Contact: Feng-Yuan Liu
• Phone: 0975365782
• Email: billliu[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Recurrence

Intervention

Diagnostic Test:
• 68Ga-FAPI-46
Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46
• 18F-FDG
Intravenous injection of one dosage of 5-10mCi 18F-FDG

Locations

Country	Name	City	State
Taiwan	Chang-Gung Memorial Hospital, Linkou Branch	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months for individual participants to complete all visits
Secondary	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.	5 years
Secondary	Overall Survival (OS)	Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death.	5 years