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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01789892
Recruitment Status : Withdrawn (no patient accrual)
First Posted : February 12, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: methylprednisolone Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Procedure: computed tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013


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 Name: tomography, computed




Primary Outcome Measures :
  1. Continuous standardized uptake values (SUV) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789892


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: David Barker, MD Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01789892    
Other Study ID Numbers: OSU-10012
NCI-2012-00530 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Fluorodeoxyglucose F18
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action