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NCT Number: NCT03824535

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

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 indeterminate 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.

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Key information

Conditions

Cigarette Smoker Behavior Current Smoker Former Smoker Health Behavior Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Pulmonary Nodule Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Cessation Thoracic Neoplasms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Diagnostic Test

Undergo PET/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Fludeoxyglucose F-18

Drug

Given IV

Other names: 18-FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Fluorine F 18 L-glutamate Derivative BAY94-9392

Drug

Given IV

Other names: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392

Positron Emission Tomography (PET/CT)

Diagnostic Test

Undergo PET/CT

Other names: Positron Emission Tomography/computer tomography, CT Scan, PET Scan, Positron Emission Tomography, medical imaging

Primary outcomes

  1. Diagnostic Performance Metrics (Sensitivity, Specificity, PPV, NPV, and Accuracy) of Ultrasonography and Capnography for Malignant Lung Nodules

    Time frame: Through study completion, an average of 2 years and 6 months

    The diagnostic performance of ultrasonography and capnography in detecting malignant lung nodules was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. Sensitivity and specificity were calculated to determine the ability to correctly identify malignant and non-malignant nodules, respectively. Results were compared to a predefined threshold of 75%, with all percentages reported as proportions of the total number of nodules analyzed. Confidence intervals were calculated for each metric to ensure precision and reliability in the estimates.

Secondary outcomes

  1. Improvement in Predictive Accuracy of Lung Nodule Diagnosis Using the C Statistic (Area Under the Curve, AUC)

    Time frame: Through study completion, an average of 2 years and 6 months

    The predictive accuracy of the lung nodule diagnosis model was assessed using the C statistic, also referred to as the area under the receiver operating characteristic (ROC) curve (AUC). Improved performance was defined as a statistically significant increase (p < 0.05) in the C statistic, determined using the DeLong test for comparing correlated ROC curves. The Mann-Whitney U test was also used to compare the distributions of the C statistic between diagnostic methods. Results are reported as the mean C statistic with 95% confidence intervals for each diagnostic method.

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Collaborators

  • Boston University
  • Canary Foundation
  • United States Department of Defense

Registry information

Official study title

18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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