COPDNCT00846573
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
A study testing Hyperpolarized Helium-3 in people with COPD and Cystic Fibrosis, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Cystic Fibrosis, Asthma
- What is being tested?
- Hyperpolarized Helium-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Medical School Advanced MRI Center United States
Worcester, Massachusetts
About this study
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.
Read the 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.
- Conditions
- COPD, Cystic Fibrosis, Asthma, Healthy
- Being tested
- Hyperpolarized Helium-3
- Keywords
- Helium, MRI, Hyperpolarized Helium, Hyperpolarized Noble Gas
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Helium-3Drug
Also called HP 3He
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.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic Participants | Experimental | 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. Receives: Drug: Hyperpolarized Helium-3 |
| Healthy | Experimental | 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. Receives: Drug: Hyperpolarized Helium-3 |
| COPD Patients | Experimental | 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. Receives: Drug: Hyperpolarized Helium-3 |
| Cystic Fibrosis Patients | Experimental | 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. Receives: Drug: Hyperpolarized Helium-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 second breath-hold
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: The study was halted prematurely as the PI was no longer an employee of UMass Medical School.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Albert, University of Massachusetts, Worcester
- Investigators
- Mitchell S Albert, Ph.D., Principal investigator, UMASS Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846573
- Sponsor's protocol ID
- Docket # 12639
- Status last verified
- Nov 2012
- First submitted
- 16 Feb 2009
- Last updated
- 15 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
- ClinicalTrials.gov ID
- NCT00846573
- Acronym / sponsor ID
- Docket # 12639
- Conditions
- COPD, Cystic Fibrosis, Asthma, Healthy
- Keywords
- Helium, MRI, Hyperpolarized Helium, Hyperpolarized Noble Gas
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted prematurely as the PI was no longer an employee of UMass Medical School.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 9 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asthmatic Participants | Experimental | Drug: Hyperpolarized Helium-3This 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. |
| Healthy | Experimental | Drug: Hyperpolarized Helium-3This 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. |
| COPD Patients | Experimental | Drug: Hyperpolarized Helium-3This 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. |
| Cystic Fibrosis Patients | Experimental | Drug: Hyperpolarized Helium-3This 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized Helium-3Also: HP 3HePatients 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. | Drug | Asthmatic Participants, COPD Patients, Cystic Fibrosis Patients, Healthy |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell S Albert, Ph.D. principal investigator
UMASS Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperpolarized Helium-3 in people with COPD and Cystic Fibrosis, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperpolarized Helium-3 MR Images (time frame: 15 second breath-hold). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.