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

Andrei Iagaru

Status and phase: Completed; Phase 2

Conditions: Cigarette Smoker; Pulmonary Nodule; Former Smoker; Current Smoker; Multiple Pulmonary Nodules

Treatments: Drug: Fludeoxyglucose F-18; Diagnostic Test: Positron Emission Tomography (PET/CT); Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392; Diagnostic Test: Computed Tomography

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03824535

NCI-2019-00177 (Registry Identifier)

IRB-46607 (Other Identifier)

LUN0106 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Computed Tomography

Diagnostic Test: Positron Emission Tomography (PET/CT)

Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392

Drug: Fludeoxyglucose F-18