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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Lung Cancer

Treatments: Diagnostic Test: 68Ga-FAPI-46

Study type: Interventional

Funder types: Other

Identifiers

NCT05617742

202101258A0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

68Ga-FAPI-46 PET Scan

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 68Ga-FAPI-46