An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

Study Overview
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Brief Summary
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The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. Assess the safety and efficacy of alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) for early diagnosis of lung cancer. SECONDARY OBJECTIVE: I. Evaluate the correlation of Me-4FDG positivity with histopathological features of the disease (tumor grade, expression of sodium-glucose cotransporter-2 inhibitors.(SGLT2). OUTLINE: Patients receive Me-4FDG tracer intravenously (IV) and then undergo PET/CT over 15 minutes. After completion of study , patients are followed up at 7 days.

Official Title
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Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

Conditions
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Lung Adenocarcinoma

Intervention / Treatment
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* Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
* Procedure: Computed Tomography
* Other: Laboratory Biomarker Analysis
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Lung nodule >= 1 cm visualized by CT imaging CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider benign the nodules with a lung-RADS score of 1-3 Exclusion Criteria: Pregnancy Diagnosis of diabetes Current treatment with SGLT2 inhibitors or metformin

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (Me-4FDG PET/CT)<br>Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes. | Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside<br>* Given IV<br>* Other names: METHYL 4-DEOXY-4-FLUORO-.ALPHA.-D-GLUCOPYRANOSIDE. F-18;Procedure: Computed Tomography<br>* Undergo PET/CT<br>* Other names: tomography;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>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 |
| --- | --- | --- |
| Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans | Will be determined by calculating the standardized uptake value (SUV) in the lesions and the contrast to noise ratio (CNR) relative to an area of normal lung surrounding the lesion, and evaluated by assessing the percentage of patients with a pathologic diagnosis of lung cancer that results positive at Me-4FDG PET scans. | within one month of surgery or biopsy | 
| Specificity of Me-4FDG for lung cancer | Will be estimated by the percentage of Me-4FDG negativity in lung nodules that have been determined radiologically and/or clinically to be benign with a lung-RAD (Lung Imaging Reporting and Data System), score 1-3. | within one week of experimental PET/CT scan | 
| Optimal combination of sensitivity and specificity | Will combine SUV and CNR cut-points that yield the optimal combination of sensitivity (positivity within the adenocarcinoma group) and specificity (negativity with the benign group). Optimality will be based on the cut-points that maximize the Youden index (sum of the sensitivity plus specificity). Based on the combined cut point, will construct 95% confidence intervals for the sensitivity and specificity. | within one week of experimental PET/CT scan | 
| Incidence of adverse events of Me-4FDG | Will tabulate the number of adverse events (AEs) and the severity of adverse events (SAEs) for the overall population as well as within subjects. | From baseline to one week after Me-4FDG administration | 
| Efficacy of Me-4FDG in diagnosing lung cancer | Will be evaluated by measuring the percentage of test positivity in patients with a pathological diagnosis of lung cancer. | within one week of the experimental PET/CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Me-4FDG positivity with histopathological features (tumor grade) | Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade. | within one month of surgery or biopsy | 
| Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2) | Will be evaluated experimentally with validated specific antibodies. | within two months of surgery or biopsy |