Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules

Study Overview
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Brief Summary
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The purpose of this study is to determine if a liquid biopsy, a method of detecting cancer from a blood draw, combined with a PET/CT scan, a type of radiological scan, is better at determining whether a lung nodule is cancerous when compared to a PET/CT scan alone. A PET/CT scan is already used for diagnosis of lung nodules, but its efficacy is uncertain in nodules 6-20 mm in size. Therefore, the PET/CT will be evaluated for its diagnostic ability in lesions this size alone and in combination with a liquid biopsy. Secondarily, a machine learning model will be created to see if the combination of the PET/CT imaging data and the liquid biopsy data can predict the presence of cancer.

Official Title
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Liquid Biopsy in Combination With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules

Conditions
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Lung Cancer, Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age ECOG performance status of 0,1, or 2 Newly discovered lung nodule with: At least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening CT No single lesion larger than 20 mm in greatest diameter when multiple nodules present High- or intermediate-risk nodules per American College of Chest Physician (ACCP) guidelines Able to provide informed consent Exclusion Criteria: Prior cancer of any type for the previous 3 years Prior organ, bone marrow, of hematopoietic stem cell transplant Contraindication to administration of [18F]FDG Inability to undergo a PET/CT scan Ongoing infection, either acute or subacute Severe COPD or lung disease requiring home oxygen use Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Pulmonary Nodule<br>Patients at high-risk of lung cancer found to have a pulmonary nodule 6-20 mm in size. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer | Determine the sensitivity and specificity of liquid biopsy and PET/CT in combination compared with PET/CT alone for predicting lung cancer for lesions 6 mm- 20 mm in size | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA gene panel ability in detecting lung cancer | Determine the sensitivity and specificity of a ctDNA gene panel in detecting lung cancer for lesions 6 mm- 200 mm in size | 24 months | 
| DNA methylation liquid biopsy ability in detecting lung cancer | Determine the sensitivity and specificity of DNA methylation liquid biopsy in detecting lung cancer for lesions 6 mm- 20 mm in size | 24 months | 
| Validate ML classifier for predicting lung cancer | Validate a machine learning (ML) classifier for predicting lung cancer using imaging and clinical data. | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET-CT Scan, Liquid Biopsies