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18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

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ClinicalTrials.gov Identifier: NCT03824535
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : March 15, 2021
Sponsor:
Collaborators:
Canary Foundation
Boston University
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 31, 2019
Last Update Posted Date March 15, 2021
Actual Study Start Date  ICMJE February 4, 2019
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules [ Time Frame: Up to 5 years ]
18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Improved performance of prediction model for lung nodules [ Time Frame: Up to 5 years ]
Improved performance is defined as a p < 0.05 increase in the C statistic determined using DeLong test for correlated receiver operating characteristic (ROC) curves.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
Official Title  ICMJE 18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cigarette Smoker
  • Current Smoker
  • Former Smoker
  • Multiple Pulmonary Nodules
  • Pulmonary Nodule
Intervention  ICMJE
  • Procedure: Computed Tomography
    Undergo PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • Drug: Fludeoxyglucose F-18
    Given IV
    Other Names:
    • 18-FDG
    • FDG
    • fludeoxyglucose F 18
    • Fludeoxyglucose F18
    • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
    • Fluorodeoxyglucose F18
  • Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
    Given IV
    Other Names:
    • (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid
    • 18F-FSPG
    • BAY94-9392
  • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE Experimental: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.
Interventions:
  • Procedure: Computed Tomography
  • Drug: Fludeoxyglucose F-18
  • Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
  • Procedure: Positron Emission Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2024
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be eligible if the dominant nodule is 7 to 30 mm
  • Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule)
  • Current or former cigarette smoker, with >= 20 pack years
  • Documented informed consent

Exclusion Criteria:

  • History or previous diagnosis of lung cancer
  • Cancer diagnosis within the last 5 years
  • Pregnant or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mahima Goel 650-723-0371 mahimag@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03824535
Other Study ID Numbers  ICMJE IRB-46607
NCI-2019-00177 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
LUN0106 ( Other Identifier: Stanford Cancer Institute Palo Alto )
IRB-46607 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrei Iagaru, Stanford University
Study Sponsor  ICMJE Andrei Iagaru
Collaborators  ICMJE
  • Canary Foundation
  • Boston University
Investigators  ICMJE
Principal Investigator: Carina M Aparici Stanford Cancer Institute Palo Alto
PRS Account Stanford University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP