CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Fluorine F 18 L-glutamate Derivative BAY94-9392 +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02448225
NCT02448225Phase 2Completed
CompareCT.gov

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

Vanderbilt-Ingram Cancer Center·interventional·Posted May 19, 2015·Updated Oct 19, 2022

In Brief

A Phase 2 clinical trial evaluating Computed Tomography, fluorodeoxyglucose F-18, and 4 other interventions for Lung Carcinoma and 2 related conditions. Completed, enrolled 46 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Carcinoma, Solitary Pulmonary Nodule, Cigarette Smoking Behavior
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 19, 2015
Enrollment StartJun 16, 2015
Primary CompletionAug 2, 2021
Study CompletionOct 10, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 11.1 years ago

Interventions

Computed Tomographyprocedure

Undergo 18F-FDG PET/CT - standard of care

Computed Tomographyprocedure

Undergo 18F-FSPG PET/CT

fluorodeoxyglucose F-18radiation

Undergo 18F-FDG PET/CT - standard of care

Fluorine F 18 L-glutamate Derivative BAY94-9392drug

Undergo 18F-FSPG PET/CT

Laboratory Biomarker Analysisother

Correlative studies

Positron Emission Tomographyprocedure

Undergo 18F-FDG PET/CT - standard of care

Positron Emission Tomography (PET)procedure

Undergo 18F-FSPG PET/CT