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

February 16, 2009
November 8, 2012
November 2008
April 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00846573 on ClinicalTrials.gov Archive Site
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Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • COPD
  • Cystic Fibrosis
  • Asthma
  • Healthy
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: 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.
    Intervention: Drug: Hyperpolarized Helium-3
  • 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.

    Intervention: Drug: Hyperpolarized Helium-3
  • 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.

    Intervention: Drug: Hyperpolarized Helium-3
  • 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.

    Intervention: Drug: Hyperpolarized Helium-3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
5 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00846573
Docket # 12639
No
Mitchell Albert, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Mitchell S Albert, Ph.D. UMASS Medical School
University of Massachusetts, Worcester
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP