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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Nodule

Intervention / Treatment
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* Drug: dexamethasone
* Procedure: PET/Computed Tomography (CT)
* Radiation: fludeoxyglucose (18F)


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Presence of ≥ 1 measurable pulmonary nodule (1.0-3.0 cm) suggestive of malignancy or chronic inflammatory process on positron emission tomography (PET) scan No lesions consistent with malignancy or inflammation according to history, PET findings, or biopsy Baseline scan average time between injection and start of scan within 50-70 min Mean liver standardized uptake value (SUV) of baseline scan normal No sign of significant partial paravenous tracer administration in the images of baseline scan No lung nodule(s) suggestive of lymphoma No lung lesions suggestive of tuberculosis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Blood glucose levels ≤ 150 mg/100 mL Not pregnant or nursing Fertile patients must use effective contraception Able to tolerate PET/CT imaging No history of diabetes No poorly controlled hypertension No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the participant has been disease free for < 3 years No active malignancy within the past 5 years PRIOR CONCURRENT THERAPY: More than 5 years since prior chemotherapy or radiotherapy No concurrent steroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/Computed Tomography (CT)<br>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 | Drug: dexamethasone<br>* Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan<br>* Other names: Decadron;Procedure: PET/Computed Tomography (CT)<br>* Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs<br>* Other names: PET Scan;Radiation: fludeoxyglucose (18F)<br>* Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs<br>* Other names: 18F-FDG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging | The blood glucose of all patients will be checked by accu-check before the injection of 18F-FDG. The acceptable blood glucose level will be ≤120 mg/dl. Any participant experienced elevated fasting blood glucose of more than 120 mg/dl after steroid therapy, he /she will be asked to come back to the PET center within 48 hours to check the blood glucose level. If the blood glucose level did not decline to baseline level, the participant will be asked to follow with his/her family doctor for management. Participants with history of systemic hypertension will be monitored for increased blood pressure. After 50-to-70 minutes period for FDG incorporation into presumed lesions, patient will under go a limited 18F-FDG PET/CT for the area of the interest (1-2 bed positions). PET imaging will be performed using a GE Discovery STE PET/CT system (GE Medical Systems, Milwaukee, WI). | 24-48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary nodule