Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: 68Ga-FAPI-46

• Registration Number: NCT05617742
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.

Detailed Description

FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-15
• Study Start: 2023-04-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Age > 20 years
2. Informed consent obtained from patients and families
3. Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
4. Patients scheduled to undergo FDG-PET examination
5. Performance status: 0, 1, 2, 3

Exclusion Criteria

1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
2. Patients with mainly malignant pleural effusion without other measurable lesions
3. Undergoing irradiation at accrual
4. Active infection or other serious underlying medical conditions not compatible with study entry
5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-46 PET Scan	68Ga-FAPI-46	A single-center prospective interventional single-arm clinical trial. All patients will undergo whole-body 68Ga-FAPI-46 PET scan within two weeks before or after 18F-FDG-PET. Injected activity of 68Ga-FAPI-46 is limited to 100-250 MBq per examination.

Primary Outcome Measures

Name	Time	Method
To define the diagnostic performance 68Ga-FAPI PET	Through study completion, 2 years	To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.

Secondary Outcome Measures

Name	Time	Method
To determine the safety profile of 68Ga-FAPI PET	Up to 7 days post injection with 68Ga-FAPI-46	Number of participants with 68Ga-FAPI-46 PET scan related adverse events assessed by CTCAE v5.0

Trial Locations

Locations (1)

Department of Nuclear Medicine, Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan