18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

Study Overview
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Brief Summary
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This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.

Detailed Description
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PRIMARY OBJECTIVES: I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether (4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between benign and malignant nodules. SECONDARY OBJECTIVES: I. To develop and validate early lung cancer detection biomarkers that would directly impact the growing need to integrate imaging and non-invasive molecular diagnostics for indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures in patients with benign lung disease. OUTLINE: Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60 minutes. After completion of study, patients are followed up within 24-72 hours.

Official Title
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18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules

Conditions
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Cigarette Smoker, Current Smoker, Former Smoker, Multiple Pulmonary Nodules, Pulmonary Nodule

Intervention / Treatment
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* Procedure: Computed Tomography
* Drug: Fludeoxyglucose F-18
* Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be eligible if the dominant nodule is 7 to 30 mm Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule) Current or former cigarette smoker, with >= 20 pack years Documented informed consent Exclusion Criteria: History or previous diagnosis of lung cancer Cancer diagnosis within the last 5 years Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 45 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: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)<br>Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes. | Procedure: Computed Tomography<br>* Undergo PET/CT<br>* Other names: tomography;Drug: Fludeoxyglucose F-18<br>* Given IV<br>* Other names: Fluorodeoxyglucose F18;Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392<br>* Given IV<br>* Other names: BAY94-9392;Procedure: Positron Emission Tomography<br>* Undergo PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules | 18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved performance of prediction model for lung nodules | Improved performance is defined as a p < 0.05 increase in the C statistic determined using DeLong test for correlated receiver operating characteristic (ROC) curves. | Up to 5 years |