Back to resultsAsthma Exacerbation and Helium-3 MRI
Primary Purpose
Asthma Exacerbation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helium-3
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma Exacerbation focused on measuring asthma, exacerbation, Helium, MRI, Lung imaging
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Able to speak and read English
- Acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent)
- FEV1 < 80% predicted on the day of MRI
- Attending physician agrees that patient is safe to participate on the day of the MRI scan
Exclusion Criteria
- Evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed)
- Documented fever or requirement for antibiotics
- Unable to hold breath for 10 seconds
- Active smoker or history of at least 10 pack years cigarette smoking
- Chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis)
- Admission to ICU
- For inpatients: contraindication to leaving hospital room for MRI as determined by Attending physician and RN on day of MRI
- Any other concurrent active pulmonary disease or other unstable or active medical condition (including suspected active coronary ischemia, acute bleeding), as determined by Attending physician
- Pregnancy as self reported
- Need for cardiac monitoring
- Need supplemental oxygen at an amount of 4L/min or a facemask
Sites / Locations
- UMASS Medical School Advanced MRI Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Asthmatics
Arm Description
All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session.
Outcomes
Primary Outcome Measures
Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT00846014
First Posted
February 16, 2009
Last Updated
September 18, 2012
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT00846014
Brief Title
Asthma Exacerbation and Helium-3 MRI
Official Title
Asthma Exacerbation and Helium-3 MRI
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Subjects which fit the strict inclusion criteria were not found.
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 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 goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs at different times of an attack. These three stages are immediately after the attack, 1 month later and 4-6 months later.
Detailed Description
Asthma is a pulmonary disorder that affects millions of people each year. The exact method of exacerbation is still under some discussion. Currently there is no cure for the disorder but treatment is of a wide variety.
This study is meant to image the asthmatic lung at various time points post exacerbation. Since pulmonary imaging is currently limited to radiation techniques, this method will allow exacerbated images without the unnecessary exposure to radiation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Exacerbation
Keywords
asthma, exacerbation, Helium, MRI, Lung imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthmatics
Arm Type
Experimental
Arm Description
All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session.
Intervention Type
Drug
Intervention Name(s)
Helium-3
Other Intervention Name(s)
Hyperpolarized Helium-3
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. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.
Primary Outcome Measure Information:
Title
Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
At least 18 years old
Able to speak and read English
Acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent)
FEV1 < 80% predicted on the day of MRI
Attending physician agrees that patient is safe to participate on the day of the MRI scan
Exclusion Criteria
Evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed)
Documented fever or requirement for antibiotics
Unable to hold breath for 10 seconds
Active smoker or history of at least 10 pack years cigarette smoking
Chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis)
Admission to ICU
For inpatients: contraindication to leaving hospital room for MRI as determined by Attending physician and RN on day of MRI
Any other concurrent active pulmonary disease or other unstable or active medical condition (including suspected active coronary ischemia, acute bleeding), as determined by Attending physician
Pregnancy as self reported
Need for cardiac monitoring
Need supplemental oxygen at an amount of 4L/min or a facemask
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
City
Worcester
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Asthma Exacerbation and Helium-3 MRI
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