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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01789892

Collaborator

(none)

Enrollment

Arm

19.1

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: methylprednisolone Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Procedure: computed tomography	N/A

Detailed Description

PRIMARY OBJECTIVES:

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diagnostic (methylprednisolone and FDG PET/CT scan) 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 Given IV Other Names: Depo-Medrol Medrol MePRDL Solu-Medrol Wyacort Radiation: fludeoxyglucose F 18 Undergo FDG PET/CT scan Other Names: 18FDG FDG Procedure: positron emission tomography Undergo FDG PET/CT scan Other Names: FDG-PET PET PET scan tomography, emission computed Procedure: computed tomography Undergo FDG PET/CT scan Other Names: tomography, computed

Arm

Intervention/Treatment

Experimental: Diagnostic (methylprednisolone and FDG PET/CT scan)

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

Given IV

Other Names:

Depo-Medrol

Medrol

MePRDL

Solu-Medrol

Wyacort

Radiation: fludeoxyglucose F 18

Undergo FDG PET/CT scan

Other Names:

18FDG

FDG

Procedure: positron emission tomography

Undergo FDG PET/CT scan

Other Names:

FDG-PET

PET

PET scan

tomography, emission computed

Procedure: computed tomography

Undergo FDG PET/CT scan

Other Names:

tomography, computed

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)