NCT02448225

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

PET Imaging of Lung Cancer and Indeterminate Pulmonary Nodules With 18F-FSPG

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET)/computed tomography (CT) to the standard of care fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common building blocks of protein) called 18F-FSPG which may be able to recognize differences between tumor and healthy tissue. Since tumor cells are growing, they need to make protein, and other building blocks, for cell growth that are made from glutamate and other molecules. PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.

Detailed description

PRIMARY OBJECTIVES: I. To compare the imaging characteristics of 18F-FSPG PET/CT with standard-of-care, 18F-FDG PET/CT. II. To compare the imaging characteristics of 18F-FSPG PET/CT to standard-of-care 18F-FDG PET/CT in patients with newly diagnosed lung cancer. III. To determine whether 18F-FSPG uptake in lung cancer can be predicted based on correlation with CD44 and amino acid transport system xc- (xC-) expression in surgical pathology specimens. OUTLINE: Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes. After completion of study, patients are followed up for 2 years if needed for diagnosis.

Conditions

• Lung Carcinoma
• Solitary Pulmonary Nodule
• Cigarette Smoking Behavior

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo 18F-FDG PET/CT - standard of care
PROCEDURE	Computed Tomography	Undergo 18F-FSPG PET/CT
RADIATION	fluorodeoxyglucose F-18	Undergo 18F-FDG PET/CT - standard of care
DRUG	Fluorine F 18 L-glutamate Derivative BAY94-9392	Undergo 18F-FSPG PET/CT
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo 18F-FDG PET/CT - standard of care
PROCEDURE	Positron Emission Tomography (PET)	Undergo 18F-FSPG PET/CT

Timeline

• Start date: 2015-06-16
• Primary completion: 2021-08-02
• Completion: 2022-10-10
• First posted: 2015-05-19
• Last updated: 2022-10-19
• Results posted: 2022-05-10

Locations

2 sites across 1 country: United States