FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
I. To assess whether premedication with a corticosteroid may reduce false positive findings
on fluorodeoxyglucose (fludeoxyglucose F 18 [FDG[) PET/computed tomography (CT) scans in
lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone
intravenously (IV) and then undergo a second FDG PET/CT scan.
After completion of study treatment, patients are followed up for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
Continuous standardized uptake values (SUV)
The SUV on the first and second PET scans will be recorded and summarized on a receiver operating characteristic (ROC) curve. We will explore the ROC curve for percent change in SUV or uptake ratio from the first to the second scan. We will explore thresholds for SUV and uptake values on the ROC curve by determining the values of acceptable combinations of true positive fractions (TPF) and false positive fractions (FPFs). We will use regression methods to adjust for possible confounding patient demographics, disease severity and disease history.
Within 1-14 days of first scan
David Barker, MD
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board