- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00846573
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States
- UMASS Medical School Advanced MRI Center United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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. |
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 Names:
|
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. |
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 Names:
|
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. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hyperpolarized Helium-3 MR Images
Time Frame: 15 second breath-hold
|
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.
|
15 second breath-hold
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Docket # 12639
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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