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

Lung Cancer Clinical Trial

Official title:

FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01789892
• Other study ID #: OSU-10012
• Secondary ID: NCI-2012-00530
• Status: Withdrawn
• Phase: N/A
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• methylprednisolone
Given IV

Radiation:
• fludeoxyglucose F 18
Undergo FDG PET/CT scan

Procedure:
• positron emission tomography
Undergo FDG PET/CT scan
• computed tomography
Undergo FDG PET/CT scan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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