Asthma Exacerbation and Helium-3 MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846014
Recruitment Status : Withdrawn (Subjects which fit the strict inclusion criteria were not found.)
First Posted : February 18, 2009
Last Update Posted : September 20, 2012
Information provided by (Responsible Party):
Mitchell Albert, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Asthma Exacerbation Drug: Helium-3 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Asthma Exacerbation and Helium-3 MRI
Study Start Date : January 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Asthmatics
All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session.
Drug: 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. 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

Primary Outcome Measures :
  1. Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846014

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

Responsible Party: Mitchell Albert, Director of Advanced MRI Center, UMASS Medical Sch, University of Massachusetts, Worcester Identifier: NCT00846014     History of Changes
Other Study ID Numbers: Docket # 12937
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by Mitchell Albert, University of Massachusetts, Worcester:
Lung imaging

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases