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

April 7, 2025 updated by: Andrei Iagaru

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: Fludeoxyglucose F-18
Given IV
Other Names:
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
  • 18-FDG
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
Diagnostic test: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Diagnostic test: Positron Emission Tomography (PET/CT)
Undergo PET/CT
Other Names:
  • CT Scan
  • PET Scan
  • Positron Emission Tomography
  • medical imaging
  • Positron Emission Tomography/computer tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrei Iagaru

Collaborators

Boston University
United States Department of Defense
Canary Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-46607 (Other Identifier: Stanford IRB)
  • NCI-2019-00177 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • LUN0106 (Other Identifier: Stanford Cancer Institute Palo Alto)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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