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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 : February 5, 2019
Sponsor:
Collaborators:
Canary Foundation
Boston University
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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
Cigarette Smoker Current Smoker Former Smoker Multiple Pulmonary Nodules Pulmonary Nodule 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:

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : February 4, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03824535


Contacts
Contact: Mahima Goel 650-723-0371 mahimag@stanford.edu

Locations
United States, California
Stanford Cancer Institute Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Mahima Goel    650-723-0371    mahimag@stanford.edu   
Principal Investigator: Sanjiv Gambhir, MD         
Sponsors and Collaborators
Andrei Iagaru
Canary Foundation
Boston University
Investigators
Principal Investigator: Sanjiv Gambhir Stanford Cancer Institute Palo Alto

Responsible Party: Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT03824535     History of Changes
Other Study ID Numbers: 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 )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
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
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Fluorides
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs