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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2021-07-30

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 indeterminate 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.

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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.

Conditions

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Cigarette Smoker Current Smoker Former Smoker Multiple Pulmonary Nodules Pulmonary Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo PET/CT

Fludeoxyglucose F-18

Intervention Type DRUG

Given IV

Fluorine F 18 L-glutamate Derivative BAY94-9392

Intervention Type DRUG

Given IV

Positron Emission Tomography (PET/CT)

Intervention Type DIAGNOSTIC_TEST

Undergo PET/CT

Interventions

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Computed Tomography

Undergo PET/CT

Intervention Type DIAGNOSTIC_TEST

Fludeoxyglucose F-18

Given IV

Intervention Type DRUG

Fluorine F 18 L-glutamate Derivative BAY94-9392

Given IV

Intervention Type DRUG

Positron Emission Tomography (PET/CT)

Undergo PET/CT

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography 18-FDG FDG fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid 18F-FSPG BAY94-9392 Positron Emission Tomography/computer tomography CT Scan PET Scan Positron Emission Tomography medical imaging

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