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FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone

18 Years
Not Enrolling
Lung Cancer

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Trial Information

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.

Inclusion Criteria:

- Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages

- Undergone clinical FDG PET/CT scan within 14 days of enrollment

Exclusion Criteria:

- Prisoners

- Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose > 180 mg/dl)

- Serious infection within 14 days of enrollment

- Known hypersensitivity to methylprednisolone

- Viral skin lesions

- Immunocompromised ANC(absolute neutrophil count < 1000/microliter)

- Pregnant/nursing

- History of tuberculosis or systemic fungal disease

- History of steroid psychosis

- Current peptic ulcer disease or diverticulitis

- Corticosteroid use within 14 days of enrollment (including inhaled steroids)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Outcome Measure:

Continuous standardized uptake values (SUV)

Outcome Description:

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.

Outcome Time Frame:

Within 1-14 days of first scan

Safety Issue:


Principal Investigator

David Barker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms