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
|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|
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.
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.
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)|
|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|
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
Drug: Fludeoxyglucose F-18
Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
Procedure: Positron Emission Tomography
- 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.
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 Goelemail@example.com|
|United States, California|
|Stanford Cancer Institute Palo Alto||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Mahima Goel 650-723-0371 firstname.lastname@example.org|
|Principal Investigator: Sanjiv Gambhir, MD|
|Principal Investigator:||Sanjiv Gambhir||Stanford Cancer Institute Palo Alto|