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

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
methylprednisolone
fludeoxyglucose F 18
positron emission tomography
computed tomography
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (methylprednisolone and FDG PET/CT scan)

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2013
    Last Updated
    June 26, 2018
    Sponsor
    Ohio State University Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01789892
    Brief Title
    Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
    Official Title
    FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no patient accrual
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ohio State University Comprehensive Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Single
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (methylprednisolone and FDG PET/CT scan)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolone
    Other Intervention Name(s)
    Depo-Medrol, Medrol, MePRDL, Solu-Medrol, Wyacort
    Intervention Description
    Given IV
    Intervention Type
    Radiation
    Intervention Name(s)
    fludeoxyglucose F 18
    Other Intervention Name(s)
    18FDG, FDG
    Intervention Description
    Undergo FDG PET/CT scan
    Intervention Type
    Procedure
    Intervention Name(s)
    positron emission tomography
    Other Intervention Name(s)
    FDG-PET, PET, PET scan, tomography, emission computed
    Intervention Description
    Undergo FDG PET/CT scan
    Intervention Type
    Procedure
    Intervention Name(s)
    computed tomography
    Other Intervention Name(s)
    tomography, computed
    Intervention Description
    Undergo FDG PET/CT scan
    Primary Outcome Measure Information:
    Title
    Continuous standardized uptake values (SUV)
    Description
    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.
    Time Frame
    Within 1-14 days of first scan

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Barker, MD
    Organizational Affiliation
    Ohio State University Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://cancer.osu.edu
    Description
    Jamesline

    Learn more about this trial

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

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