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

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Estado

Patrocinadores

Ohio State University Comprehensive Cancer Center

ENSAYO CLÍNICO: NCT01789892

BioSeek: nct01789892

Palabras clave

Abstracto

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

Descripción

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.

fechas

Verificado por última vez:	05/31/2018
Primero enviado:	02/07/2013
Inscripción estimada enviada:	02/07/2013
Publicado por primera vez:	02/11/2013
Última actualización enviada:	06/25/2018
Última actualización publicada:	06/27/2018
Fecha de inicio real del estudio:	05/31/2011
Fecha estimada de finalización primaria:	12/31/2012
Fecha estimada de finalización del estudio:	12/31/2012

Condición o enfermedad

Lung Cancer

Intervención / tratamiento

Drug: Diagnostic (methylprednisolone and FDG PET/CT scan)

Radiation: Diagnostic (methylprednisolone and FDG PET/CT scan)

Procedure: Diagnostic (methylprednisolone and FDG PET/CT scan)

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
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: Diagnostic (methylprednisolone and FDG PET/CT scan) Given IV

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	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)

Salir

Medidas de resultado primarias

1. Continuous standardized uptake values (SUV) [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.

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

Palabras clave

cáncer de pulmón

cáncer

inflamación

antiinflamatorio