Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00906503
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : September 29, 2014
Last Update Posted : April 7, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Pulmonary Nodule Drug: dexamethasone Procedure: PET/Computed Tomography (CT) Radiation: fludeoxyglucose (18F) Phase 1

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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?
Study Start Date : April 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: PET/Computed Tomography (CT)
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
Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
Other Name: Decadron

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
Other Name: PET Scan

Radiation: fludeoxyglucose (18F)
Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Other Names:
  • Radioactive tracer
  • 18F-FDG

Primary Outcome Measures :
  1. Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging [ Time Frame: 24-48 hours ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • More than 5 years since prior chemotherapy or radiotherapy
  • No concurrent steroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00906503

Layout table for location information
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Majid Khalaf, MD Barbara Ann Karmanos Cancer Institute

Layout table for additonal information
Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00906503     History of Changes
Other Study ID Numbers: CDR0000642256
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2009    Key Record Dates
Results First Posted: September 29, 2014
Last Update Posted: April 7, 2015
Last Verified: March 2015

Keywords provided by Barbara Ann Karmanos Cancer Institute:
pulmonary nodule

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Dexamethasone acetate
BB 1101
Fluorodeoxyglucose F18
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action