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Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

This study has been terminated.
(The study was halted prematurely as the PI was no longer an employee of UMass Medical School.)
Sponsor:
Information provided by (Responsible Party):
Mitchell Albert, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00846573
First received: February 16, 2009
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.


Condition Intervention
COPD
Cystic Fibrosis
Asthma
Healthy
 Drug: Hyperpolarized Helium-3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Hyperpolarized Helium-3 MR Images [ Time Frame: 15 second breath-hold ] [ Designated as safety issue: No ]
    We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.


Enrollment: 14
Study Start Date: November 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asthmatic Participants
This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
 Drug: Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
Other Name: HP 3He
Experimental: Healthy

This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.

Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

 Drug: Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
Other Name: HP 3He
Experimental: COPD Patients

This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.

Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

 Drug: Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
Other Name: HP 3He
Experimental: Cystic Fibrosis Patients

This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.

Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

 Drug: Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
Other Name: HP 3He

Detailed Description:

Current pulmonary imaging techniques are clinically regulated to machines that produce radiation. MR which does not produce radiation was not possible due to the low concentration of fluids in the open spaces of the lungs. With hyperpolarized noble gases we can now use the safe techniques of MR imaging to view the airways of the lungs, thus limiting human exposure to radiation. This technique has already been proven to be possible in human subjects but there is insufficient data show its efficacy in a clinical setting. This study is designed to image a variety of pulmonary disorders to better find possible clinical uses for hyperpolarized gas MRI.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are male or female and are 5 years or older
  • Consent/assent from the patient
  • Have been diagnosed with a pulmonary disease such as COPD, Asthma, or cystic fibrosis. OR Healthy Individuals.
  • Must be able to hold their breath for up to 15 seconds

Exclusion Criteria:

  • Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;
  • Are undergoing the MR exam in an emergency situation
  • Are pregnant or become pregnant at any point within the study time.
  • People with psychiatric disorders will be excluded from the study.
  • Are claustrophobic and can not tolerate the imaging.
  • Uses supplemental oxygen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846573

Locations
United States, Massachusetts
UMASS Medical School Advanced MRI Center United States
Worcester, Massachusetts, United States
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Mitchell S Albert, Ph.D. UMASS Medical School
  More Information

No publications provided

Responsible Party: Mitchell Albert, Director of Advanced MRI Center, UMASS Medical Sch, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00846573     History of Changes
Other Study ID Numbers: Docket # 12639
Study First Received: February 16, 2009
Results First Received: August 21, 2012
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Massachusetts, Worcester:
Helium
MRI
Hyperpolarized Helium
Hyperpolarized Noble Gas

Additional relevant MeSH terms:
Asthma
Cystic Fibrosis
Fibrosis
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013