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

Multiple Pulmonary Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03824535
• Other study ID #: IRB-46607
• Secondary ID: NCI-2019-00177LU
• Status: Recruiting
• Phase: Phase 2
• Start date: February 4, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Mahima Goel
• Phone: 650-723-0371
• Email: mahimag[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT

Drug:
• Fludeoxyglucose F-18
Given IV
• Fluorine F 18 L-glutamate Derivative BAY94-9392
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	Stanford Cancer Institute Palo Alto	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Andrei Iagaru	Boston University, Canary Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules	18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%.	Up to 5 years
Secondary	Improved performance of prediction model for lung nodules	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.	Up to 5 years