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

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The Ohio State University

Status

Withdrawn

Conditions

Lung Cancer

Treatments

Radiation: fludeoxyglucose F 18
Drug: methylprednisolone
Procedure: positron emission tomography
Procedure: computed tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT01789892
NCI-2012-00530 (Registry Identifier)
OSU-10012

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

0 participants in 1 patient group

Diagnostic (methylprednisolone and FDG PET/CT scan)
Experimental group
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.
Treatment:
Procedure: computed tomography
Procedure: positron emission tomography
Drug: methylprednisolone
Radiation: fludeoxyglucose F 18

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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