Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00906503
First received: May 20, 2009
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
    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).


Enrollment: 9
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906503

Locations
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
Investigators
Principal Investigator: Majid Khalaf, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00906503     History of Changes
Other Study ID Numbers: CDR0000642256, P30CA022453, WSU-2008-075
Study First Received: May 20, 2009
Results First Received: September 23, 2014
Last Updated: September 23, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
pulmonary nodule

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fluorodeoxyglucose F18
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014