Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
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.
Procedure: computed tomography
Radiation: fludeoxyglucose F 18
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules?|
- Feasibility of ultra short-term steroid therapy (24-48 hours) to increase the accuracy of FDG-PET/CT imaging [ Designated as safety issue: No ]
- Overall sensitivity and specificity of the nodules group [ Designated as safety issue: No ]
- Effect-size estimate [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906503
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Detroit, Michigan, United States, 48235|
|Principal Investigator:||Majid Khalaf, MD||Barbara Ann Karmanos Cancer Institute|