search
Back to results

Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

Primary Purpose

COPD, Cystic Fibrosis, Asthma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Helium-3
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD focused on measuring Helium, MRI, Hyperpolarized Helium, Hyperpolarized Noble Gas

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UMASS Medical School Advanced MRI Center United States

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Asthmatic Participants

Healthy

COPD Patients

Cystic Fibrosis Patients

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Hyperpolarized Helium-3 MR Images
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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2009
Last Updated
November 8, 2012
Sponsor
University of Massachusetts, Worcester
search

1. Study Identification

Unique Protocol Identification Number
NCT00846573
Brief Title
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
Official Title
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was halted prematurely as the PI was no longer an employee of UMass Medical School.
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Cystic Fibrosis, Asthma, Healthy
Keywords
Helium, MRI, Hyperpolarized Helium, Hyperpolarized Noble Gas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthmatic Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy
Arm Type
Experimental
Arm Description
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.
Arm Title
COPD Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Cystic Fibrosis Patients
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Hyperpolarized Helium-3
Other Intervention Name(s)
HP 3He
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hyperpolarized Helium-3 MR Images
Description
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.
Time Frame
15 second breath-hold

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S Albert, Ph.D.
Organizational Affiliation
UMASS Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMASS Medical School Advanced MRI Center United States
City
Worcester
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

We'll reach out to this number within 24 hrs