Trial | NCT03824535  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    50
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.
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.
Study Started
Feb 04
2019
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2025
Anticipated
Last Update
Mar 08
2023

Procedure Computed Tomography

Undergo PET/CT

  • Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Drug Fludeoxyglucose F-18

Given IV

  • Other names: 18-FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Drug Fluorine F 18 L-glutamate Derivative BAY94-9392

Given IV

  • Other names: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392

Procedure Positron Emission Tomography

Undergo PET/CT

  • Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

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.

Criteria 

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
No Results Posted