Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
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.
  • Procedure: Computed Tomography
    Undergo 18F-FDG PET/CT - standard of care
    Other names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • Computerized Tomography
    • CT
    • CT SCAN
    • tomography
  • Procedure: Computed Tomography
    Undergo 18F-FSPG PET/CT
    Other names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • Computerized Tomography
    • CT
    • CT SCAN
    • tomography
  • Radiation: fluorodeoxyglucose F-18
    Undergo 18F-FDG PET/CT - standard of care
    Other names:
    • 18FDG
    • FDG
    • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
    Undergo 18F-FSPG PET/CT
    Other names:
    • (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid
    • 18F-FSPG
    • BAY94-9392
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Positron Emission Tomography
    Undergo 18F-FDG PET/CT - standard of care
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET SCAN
    • Positron Emission Tomography Scan
    • proton magnetic resonance spectroscopic imaging
  • Procedure: Positron Emission Tomography (PET)
    Undergo 18F-FSPG PET/CT
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • Positron Emission Tomography Scan
    • proton magnetic resonance spectroscopic imaging

More Details

Status
Completed
Sponsor
Vanderbilt-Ingram Cancer Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.