Clinical Trial: Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules?
Brief Summary:
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before and after steroid therapy may help doctors assess a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and after ultra short-term dexamethasone therapy to see how well it measures changes in nodules in patients with lung nodules.
Detailed Summary:
OBJECTIVES:
- To determine whether ultra short-term steroid therapy (24-48 hours) can be used to increase the accuracy of fludeoxyglucose F 18 positron emission tomography/computed tomography (FDG-PET/CT) imaging in categorizing nodules in patients with pulmonary nodules.
- To calculate the overall sensitivity and specificity of the nodules group, based on FDG uptake, for predicting malignancy.
- To gather effect-size estimates that will be used to improve the quality of a larger follow-up study.
OUTLINE: Patients receive oral dexamethasone at 40, 28, 16, and 4 hours before imaging. Patients undergo fludeoxyglucose F 18 (FDG)-positron emission tomography/computed tomography (PET/CT) imaging at baseline and upon completion of steroid therapy.
After completion of study therapy, patients are followed for 6 months.
Sponsor: Barbara Ann Karmanos Cancer Institute
Current Primary Outcome: Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging [ Time Frame: 24-48 hours ]
Original Primary Outcome:
- Feasibility of ultra short-term steroid therapy (24-48 hours) to increase the accuracy of FDG-PET/CT imaging
- Overall sensitivity and specificity of the nodules group
- Effect-size estimate
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Barbara Ann Karmanos Cancer Institute
Dates:
Date Received: May 20, 2009
Date Started: April 2009
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015