18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Condition: Lung Carcinoma; Solitary Pulmonary Nodule; Cigarette Smoking Behavior
MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)
      positron emission tomography (PET)/computed tomography (CT) to the standard of care
      fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer
      or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common
      building blocks of protein) called 18F-FSPG which may be able to recognize differences
      between tumor and healthy tissue. Since tumor cells are growing, they need to make protein,
      and other building blocks, for cell growth that are made from glutamate and other molecules.
      PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer
      than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To compare the imaging characteristics of 18F-FSPG PET/CT with standard-of-care, 18F-FDG
      PET/CT.

      II. To compare the imaging characteristics of 18F-FSPG PET/CT to standard-of-care 18F-FDG
      PET/CT in patients with newly diagnosed lung cancer.

      III. To determine whether 18F-FSPG uptake in lung cancer can be predicted based on
      correlation with CD44 and amino acid transport system xc- (xC-) expression in surgical
      pathology specimens.

      OUTLINE:

      Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients
      also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30
      minutes.

      After completion of study, patients are followed up for 2 years if needed for diagnosis.
    

Intervention name(s): Computed Tomography; Computed Tomography; fluorodeoxyglucose F-18; Fluorine F 18 L-glutamate Derivative BAY94-9392; Laboratory Biomarker Analysis; Positron Emission Tomography; Positron Emission Tomography (PET)
Intervention type(s): Procedure; Procedure; Radiation; Drug; Other; Procedure; Procedure
Intervention description(s): Undergo 18F-FDG PET/CT - standard of care; Undergo 18F-FSPG PET/CT; Undergo 18F-FDG PET/CT - standard of care; Undergo 18F-FSPG PET/CT; Correlative studies; Undergo 18F-FDG PET/CT - standard of care; Undergo 18F-FSPG PET/CT
Other intervention name(s): CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT; CT SCAN; tomography; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT; CT SCAN; tomography; 18FDG; FDG; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid; 18F-FSPG; BAY94-9392; Medical Imaging, Positron Emission Tomography; PET; PET SCAN; Positron Emission Tomography Scan; proton magnetic resonance spectroscopic imaging; Medical Imaging, Positron Emission Tomography; Positron Emission Tomography Scan; proton magnetic resonance spectroscopic imaging
Intervention MeSH terms: Deoxyglucose; Fluorides; Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic