Study Stopped
no patient accrual
Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
2 other identifiers
interventional
N/A
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedJune 28, 2018
June 1, 2018
1.6 years
February 8, 2013
June 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Diagnostic (methylprednisolone and FDG PET/CT scan)
EXPERIMENTALWithin 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
Interventions
Given IV
Undergo FDG PET/CT scan
Undergo FDG PET/CT scan
Undergo FDG PET/CT scan
Eligibility Criteria
You may qualify if:
- Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
- Undergone clinical FDG PET/CT scan within 14 days of enrollment
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Barker, MD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 12, 2013
Study Start
June 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
June 28, 2018
Record last verified: 2018-06