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

Not Applicable

Withdrawn

• Conditions: Lung Cancer
• Interventions: Drug: methylprednisolone; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: computed tomography

• Registration Number: NCT01789892
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (methylprednisolone and FDG PET/CT scan)	positron emission tomography	Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
Diagnostic (methylprednisolone and FDG PET/CT scan)	computed tomography	Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
Diagnostic (methylprednisolone and FDG PET/CT scan)	methylprednisolone	Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
Diagnostic (methylprednisolone and FDG PET/CT scan)	fludeoxyglucose F 18	Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.

Primary Outcome Measures

Name	Time	Method
Continuous standardized uptake values (SUV)	Within 1-14 days of first scan	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.