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

Sponsor
Andrei Iagaru (Other)
Overall Status
Recruiting
CT.gov ID
NCT03824535
Collaborator
Canary Foundation (Other), Boston University (Other)
50
Enrollment
1
Location
1
Arm
65.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Drug: Fludeoxyglucose F-18
  • Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
  • Procedure: Positron Emission Tomography
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
Actual Study Start Date :
Feb 4, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules [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%.

    Secondary Outcome Measures

    1. Improved performance of prediction model for lung nodules [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304

    Sponsors and Collaborators

    • Andrei Iagaru
    • Canary Foundation
    • Boston University

    Investigators

    • Principal Investigator: Carina M Aparici, Stanford Cancer Institute Palo Alto

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine), Stanford University
    ClinicalTrials.gov Identifier:
    NCT03824535
    Other Study ID Numbers:
    • IRB-46607
    • NCI-2019-00177
    • LUN0106
    • IRB-46607
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules
    Deoxyglucose
    Fluorodeoxyglucose F18
    Fluorides

    Study Results

    No Results Posted as of Jun 23, 2022