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18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

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ClinicalTrials.gov Identifier: NCT02448225
Recruitment Status : Active, not recruiting
First Posted : May 19, 2015
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Chirayu Shah, Vanderbilt-Ingram Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Carcinoma Solitary Pulmonary Nodule Cigarette Smoking Behavior Procedure: Computed Tomography Radiation: fluorodeoxyglucose F-18 Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392 Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography Procedure: Positron Emission Tomography (PET) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Imaging of Lung Cancer and Indeterminate Pulmonary Nodules With 18F-FSPG
Actual Study Start Date : June 16, 2015
Actual Primary Completion Date : January 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Ability of 18F-FSPG PET/CT to discriminate benign from malignant nodules [ Time Frame: Up to 2 years ]
    Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests.

  2. Ability of 18F-FSPG PET/CT to stage of lung cancer [ Time Frame: Up to 2 years ]
    Sensitivity, specificity, overall accuracy and ROC curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests.


Secondary Outcome Measures :
  1. CD44 and xC- expression levels in tissue samples [ Time Frame: Up to 2 years ]
    Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of immunohistochemical staining (CD44 and xC- expression levels).

  2. Uptake of 18F-FSPG (expressed in maximal standardized uptake value [SUV] within the tumor, average SUV within tumor, and peak SUV) [ Time Frame: Up to 2 years ]
    Descriptive statistics, including means, standard deviations, and ranges for continuous parameters normalized to lean body mass, and ratios of these uptake values to cardiac blood pool.


Other Outcome Measures:
  1. Uptake of 18F-FSPG (expressed in maximal standardized uptake value [SUV] within the [ Time Frame: Up to 2 years ]
    Descriptive statistics, including means, standard deviations, and ranges for continuous



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448225


Locations
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United States, Tennessee
Tennessee Valley Health System Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Pierre Massion, MD Vanderbilt-Ingram Cancer Center
Additional Information:
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Responsible Party: Chirayu Shah, Associate Professor of Clinical Radiology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02448225    
Other Study ID Numbers: VICC THO 1524
NCI-2015-00748 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Deoxyglucose
Fluorides
Fluorodeoxyglucose F18
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents