Conditions: Pulmonary Nodule
Keywords: pulmonary nodule
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

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 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.

Arms:
arm 1: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Interventions: intervention 1: dexamethasone intervention 2: PET/Computed Tomography (CT) intervention 3: fludeoxyglucose (18F)
Intervention descriptions: intervention 1: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan intervention 2: Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs intervention 3: Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Protocol document: