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

NCT03824535 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-46607NCI-2019-00177LUN0106
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

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

Keywords

Indeterminate lung nodule

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

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

Study Arms (1)

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

EXPERIMENTAL

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.

Diagnostic Test: Computed Tomography; Drug: Fludeoxyglucose F-18; Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392; Diagnostic Test: Positron Emission Tomography (PET/CT)

Interventions

Computed Tomography DIAGNOSTIC_TEST

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

Fludeoxyglucose F-18 DRUG

Given IV

Also known as: 18-FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

Fluorine F 18 L-glutamate Derivative BAY94-9392 DRUG

Given IV

Also known as: (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

Positron Emission Tomography (PET/CT) DIAGNOSTIC_TEST

Undergo PET/CT

Also known as: Positron Emission Tomography/computer tomography, CT Scan, PET Scan, Positron Emission Tomography, medical imaging

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History or previous diagnosis of lung cancer
• Cancer diagnosis within the last 5 years
• Pregnant or nursing

Sponsors & Collaborators

• Andrei Iagaru: lead
• Canary Foundation: collaborator
• Boston University: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Multiple Pulmonary Nodules

Interventions

Tomography, X-Ray Computed; Tomography; Fluorodeoxyglucose F18; 4-(3-fluoropropyl)glutamic acid; Positron-Emission Tomography; Positron Emission Tomography Computed Tomography; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Deoxyglucose; Deoxy Sugars; Carbohydrates; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope; Multimodal Imaging

Results Point of Contact

• Title: Dr. Carina Mari Aparici
• Organization: Stanford University

drmari@stanford.edu

650-497 9280

Study Officials

• Carina Mari Aparici

  Stanford Cancer Institute Palo Alto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology (Nuclear Medicine)

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: February 4, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)