Asthma Exacerbation and Helium-3 MRI
This study has been withdrawn prior to enrollment.
(Subjects which fit the strict inclusion criteria were not found.)
Information provided by (Responsible Party):
Mitchell Albert, University of Massachusetts, Worcester
First received: February 16, 2009
Last updated: September 18, 2012
Last verified: September 2012
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Asthma Exacerbation and Helium-3 MRI
Primary Outcome Measures:
- Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session.
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.
Other Name: Hyperpolarized Helium-3
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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: NCT00846014
|UMASS Medical School Advanced MRI Center
|Worcester, Massachusetts, United States |
University of Massachusetts, Worcester
||Mitchell S Albert, Ph.D.
||UMASS Medical School
||Mitchell Albert, Director of Advanced MRI Center, UMASS Medical Sch, University of Massachusetts, Worcester
History of Changes
|Other Study ID Numbers:
Docket # 12937
|Study First Received:
||February 16, 2009
||September 18, 2012
||United States: Food and Drug Administration
Keywords provided by University of Massachusetts, Worcester:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases