Asthma, COPD, Cystic Fibrosis, Healthy
Conditions
Keywords
Helium, MRI, Hyperpolarized Helium, Hyperpolarized Noble Gas
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.
Interventions
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.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperpolarized Helium-3 MR Images | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment began November 2008 and enrollment started January 2009. Recruitment continued until the study was terminated, April 2011. Participants were asthmatics, COPD patients, or CF patients as confirmed by their physician. Recruitment was completed from the UMass Memorial Medical Centre. Alternatively, healthy volunteers were also recruited.
Pre-assignment details
Participants were excluded if their diagnosis of a lung condition could not be confirmed by medical records.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Asthma Patients 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. | 2 |
| 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. | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Asthma Patients | Cystic Fibrosis Patients | COPD Patients | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 7 Participants | 4 Participants | 13 Participants |
| Age Continuous | 34.5 years STANDARD_DEVIATION 14.85 | 27 years STANDARD_DEVIATION 8.25 | 24.4 years STANDARD_DEVIATION 9.74 | 27.14 years STANDARD_DEVIATION 9.42 |
| Region of Enrollment United States | 2 participants | 7 participants | 5 participants | 14 participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 2 | 0 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 | 0 / 7 |
Outcome results
Primary
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.
Time frame: 15 second breath-hold
Population: We recruited participants of each category until we were satisfied with the images we obtained.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COPD Patients | Hyperpolarized Helium-3 MR Images | 5 participants |
| Asthma Patients | Hyperpolarized Helium-3 MR Images | 2 participants |
| Cystic Fibrosis Patients | Hyperpolarized Helium-3 MR Images | 7 participants |