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

Pulmonary Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906503
• Other study ID #: CDR0000642256
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2009
• Last updated: March 18, 2015
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2015
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule

Intervention

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

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Sinai-Grace Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No