Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
Information source: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: methylprednisolone (Drug); fludeoxyglucose F 18 (Radiation); positron emission tomography (Procedure); computed tomography (Procedure)
Phase: N/A
Status: Withdrawn
Sponsored by: Ohio State University Comprehensive Cancer Center Official(s) and/or principal investigator(s):
David Barker, MD, Principal Investigator, Affiliation: Ohio State University Comprehensive Cancer Center
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
Clinical Details
Official title: FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
Primary outcome: Continuous standardized uptake values (SUV)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
Jamesline
Starting date: June 2011
Last updated: February 8, 2013
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