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Brief Title: 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
Official Title: 18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
Study ID: NCT03824535
Brief 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 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.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Name: Carina M Aparici
Affiliation: Stanford Cancer Institute Palo Alto
Role: PRINCIPAL_INVESTIGATOR