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

Study Overview
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Brief Summary
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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
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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.

Official Title
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68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: 68Ga-FAPI-46


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 20 years Informed consent obtained from patients and families Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery Patients scheduled to undergo FDG-PET examination Performance status: 0, 1, 2, 3 Exclusion Criteria: Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients Patients with mainly malignant pleural effusion without other measurable lesions Undergoing irradiation at accrual Active infection or other serious underlying medical conditions not compatible with study entry History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI-46 PET Scan<br>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. | Diagnostic Test: 68Ga-FAPI-46<br>* 68Ga-FAPI-46 is a radioactive diagnostic agent for PET imaging in the detection of Fibroblast Activation Protein (FAP) positive tumor cells in cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the diagnostic performance 68Ga-FAPI PET | 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. | Through study completion, 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-FAPI-46, Lung Cancer