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
Intervention: 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 description: 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
Intervention MeSH terms: Deoxyglucose; Fluorides; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

        - Have an indeterminate untreated pulmonary nodule (IPN) (7-30 mm diameter) on CT, or an
        indeterminate lung mass (> 30 mm diameter), without prior examinations that establish that
        the lesion has been stable for two or more years, untreated.

        or

          -  Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more.

          -  Be able to give informed consent, which will include a layman's explanation of the
             estimated amount of additional radiation that the patient will receive from the
             investigational PET/CT scan using 18F-FSPG

          -  Must agree at the time of study entry to undergo clinically indicated biopsy(ies) or a
             24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or
             lung mass(es).

        Exclusion Criteria:

          -  Pregnant or lactating patients will be excluded, as will females of childbearing
             potential who refuse to undergo a serum or urinary beta-HCG pregnancy test the day of
             either the 18F-FSPG or the 18F-FDG PET/CT scans, in accordance with the standard
             policy of the Medical Imaging Service at our facility. Women who have experienced 24
             consecutive months of amenorrhea, have reached at least 60 years of age, or have had a
             tubal ligation or hysterectomy documented in their medical records are considered not
             to be of childbearing potential for the purposes of this protocol

          -  Patients with a body weight of 400 pounds or more or a body habitus or disability that
             will not permit the imaging protocol to be performed

          -  A recognized active lung infection

          -  Previous systemic or radiation treatment for cancer of any type within 1 year

          -  For patients who do not have a tissue diagnosis:

               -  Non-oncologic severe co-morbidities suggesting a life span of less than two years
                  if not treated, as determined by the potential subject's treating physician.