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

The Ohio State University

Status: Withdrawn

Conditions: Lung Cancer

Treatments: Radiation: fludeoxyglucose F 18; Drug: methylprednisolone; Procedure: positron emission tomography; Procedure: computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT01789892

NCI-2012-00530 (Registry Identifier)

OSU-10012

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 1 patient group

Diagnostic (methylprednisolone and FDG PET/CT scan)

Experimental group

Description:

Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.

Treatment:

Procedure: computed tomography

Procedure: positron emission tomography

Drug: methylprednisolone

Radiation: fludeoxyglucose F 18