Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer

Ohio State University Comprehensive Cancer Center

Overview

The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation

PRIMARY OBJECTIVES: 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 inflammation. OUTLINE: 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Lung Cancer

Interventions

methylprednisoloneDRUG

Given IV

fludeoxyglucose F 18RADIATION

Undergo FDG PET/CT scan

positron emission tomographyPROCEDURE

Undergo FDG PET/CT scan

computed tomography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included) * 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)

Outcomes

Primary Outcomes

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.

Time frame: Within 1-14 days of first scan

Data from ClinicalTrials.gov

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