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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
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 : | February 4, 2019 |
Estimated Primary Completion Date : | August 1, 2022 |
Estimated Study Completion Date : | August 1, 2024 |

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.
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Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Drug: Fludeoxyglucose F-18 Given IV
Other Names:
Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392 Given IV
Other Names:
Procedure: Positron Emission Tomography Undergo PET/CT
Other Names:
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- 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%.
- 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 |
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

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
Contact: Mahima Goel | 650-723-0371 | mahimag@stanford.edu |
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: Carina M Aparici, MD |
Principal Investigator: | Carina M Aparici | Stanford Cancer Institute Palo Alto |
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 ( 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: | March 15, 2021 |
Last Verified: | March 2021 |
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 |
Multiple Pulmonary Nodules Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Deoxyglucose Fluorodeoxyglucose F18 |
Fluorides Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action Cariostatic Agents Protective Agents Physiological Effects of Drugs Antimetabolites Antiviral Agents Anti-Infective Agents |