NCT03824535

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cigarette Smoker
• Current Smoker
• Former Smoker
• Multiple Pulmonary Nodules
• Pulmonary Nodule

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Computed Tomography	Undergo PET/CT
DRUG	Fludeoxyglucose F-18	Given IV
DRUG	Fluorine F 18 L-glutamate Derivative BAY94-9392	Given IV
DIAGNOSTIC_TEST	Positron Emission Tomography (PET/CT)	Undergo PET/CT

Timeline

• Start date: 2019-02-04
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2019-01-31
• Last updated: 2025-04-09
• Results posted: 2025-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study