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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: methylprednisolone
* Radiation: fludeoxyglucose F 18
* Procedure: positron emission tomography
* Procedure: computed tomography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (methylprednisolone and FDG PET/CT scan)<br>Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan. | Drug: methylprednisolone<br>* Given IV<br>* Other names: Wyacort;Radiation: fludeoxyglucose F 18<br>* Undergo FDG PET/CT scan<br>* Other names: FDG;Procedure: positron emission tomography<br>* Undergo FDG PET/CT scan<br>* Other names: tomography, emission computed;Procedure: computed tomography<br>* Undergo FDG PET/CT scan<br>* Other names: tomography, computed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |