NCT00906503

Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules

Does Ultra Short-term Steroid Therapy Increase the Accuracy of FDG-PET/CT in Evaluation of Pulmonary Nodules?

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Pulmonary Nodule

Interventions

Type	Name	Description
DRUG	dexamethasone	Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
PROCEDURE	PET/Computed Tomography (CT)	Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
RADIATION	fludeoxyglucose (18F)	Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-02-01
• Completion: 2012-04-01
• First posted: 2009-05-21
• Last updated: 2015-04-07
• Results posted: 2014-09-29

Locations

2 sites across 1 country: United States