Radiation ExposurePhase 4NCT03776747
Repeatability in Hyperpolarized 3-Helium With MRI
A Phase 4 study testing Prone hyperpolarized 3 helium gas scan, Supine hyperpolarized 3 helium gas scan and Vitals in people with Radiation Exposure, run by Eric A. Hoffman at 1 site in United States.
Trial summary
The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Prone hyperpolarized 3 helium gas scan, Supine hyperpolarized 3 helium gas scan and Vitals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2008to Jun 2012
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be between the ages of 18 and 90
- must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.
Who cannot join
- if female, must not be pregnant or breastfeeding
- must not have any metal objects in or on their body including body piercings that cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc., pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or neurostimulation.
- must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm, hemodynamic instability, kidney dysfunction or heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging
The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects.
Read the detailed description
New CT imaging techniques often expose the patient to higher doses of radiation. There is a great deal of concern about effects of medical radiation exposure on the general public and regulations are becoming stricter on the radiation doses that are allowed.
One novel procedure that has been developed to evaluate the function and structure of the lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung imaging techniques that we have developed in our lab to a technique that uses hyperpolarized 3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung imaging techniques.
Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging to take place. The use of hyperpolarized 3-Helium has a few advantages:
- it allows us to see the microstructure of the lungs through diffusion imaging (apparent diffusion coefficient) which correlates with the size of airways and alveolar space.
- it allows us to see ventilation, or how air moves in the lungs, at a high resolution.
- it is capable of ultra fast imaging which will help us assess gas flow patterns within the airways. and 4) the speed of depolarization lets us measure the partial pressure of oxygen and associated gas exchange mechanisms.
- Conditions
- Radiation Exposure
- Being tested
- Prone hyperpolarized 3 helium gas scan, Supine hyperpolarized 3 helium gas scan, Vitals, Pulmonary Function Tests, Initial protocol MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone hyperpolarized 3 helium gas scanDrug
Also called Prone MRI scan with contrast
Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Supine hyperpolarized 3 helium gas scanDrug
Also called Supine MRI scan with contrast
Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
VitalsDiagnostic test
Pulmonary Function TestsDiagnostic test
Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scanDiagnostic test
Initial scan to determine placement
| Study group | Role | What they receive |
|---|---|---|
| Group One: Prone MRI Scans | Experimental | Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan Receives: Drug: Prone hyperpolarized 3 helium gas scan; Diagnostic Test: Vitals; Diagnostic Test: Pulmonary Function Tests; Diagnostic Test: Initial protocol MRI scan |
| Group Two: Supine MRI scans | Active comparator | Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan Receives: Drug: Supine hyperpolarized 3 helium gas scan; Diagnostic Test: Vitals; Diagnostic Test: Pulmonary Function Tests; Diagnostic Test: Initial protocol MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.
Measured: Through study completion, measurements completed at one day visit only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start22 Jul 2008
- Primary completionJun 2012
- Study completionJun 2012
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 Radiation ExposureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric A. Hoffman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric A. Hoffman, University of Iowa
- Investigators
- Eric A Hoffman, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776747
- Sponsor's protocol ID
- 200803776
- Status last verified
- Oct 2023
- First submitted
- 13 Dec 2018
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03776747
- Acronym / sponsor ID
- 200803776
- Conditions
- Radiation Exposure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eric A. HoffmanUniversity, hospital or other
- Study start
- 22 Jul 2008 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects.
Detailed description
New CT imaging techniques often expose the patient to higher doses of radiation. There is a great deal of concern about effects of medical radiation exposure on the general public and regulations are becoming stricter on the radiation doses that are allowed.
One novel procedure that has been developed to evaluate the function and structure of the lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung imaging techniques that we have developed in our lab to a technique that uses hyperpolarized 3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung imaging techniques.
Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging to take place. The use of hyperpolarized 3-Helium has a few advantages:
- it allows us to see the microstructure of the lungs through diffusion imaging (apparent diffusion coefficient) which correlates with the size of airways and alveolar space.
- it allows us to see ventilation, or how air moves in the lungs, at a high resolution.
- it is capable of ultra fast imaging which will help us assess gas flow patterns within the airways. and 4) the speed of depolarization lets us measure the partial pressure of oxygen and associated gas exchange mechanisms.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group One: Prone MRI Scans | Experimental | Drug: Prone hyperpolarized 3 helium gas scan, Diagnostic Test: Vitals, Diagnostic Test: Pulmonary Function Tests, Diagnostic Test: Initial protocol MRI scanSubjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan |
| Group Two: Supine MRI scans | Active comparator | Drug: Supine hyperpolarized 3 helium gas scan, Diagnostic Test: Vitals, Diagnostic Test: Pulmonary Function Tests, Diagnostic Test: Initial protocol MRI scanSubjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must be between the ages of 18 and 90
- must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.
Key exclusion criteria (3 listed)
- if female, must not be pregnant or breastfeeding
- must not have any metal objects in or on their body including body piercings that cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc., pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or neurostimulation.
- must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm, hemodynamic instability, kidney dysfunction or heart disease.
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 |
|---|---|---|
| Prone hyperpolarized 3 helium gas scanAlso: Prone MRI scan with contrastHyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone. | Drug | Group One: Prone MRI Scans |
| Supine hyperpolarized 3 helium gas scanAlso: Supine MRI scan with contrastHyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine. | Drug | Group Two: Supine MRI scans |
| Vitals | Diagnostic test | Group One: Prone MRI Scans, Group Two: Supine MRI scans |
| Pulmonary Function TestsPre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes | Diagnostic test | Group One: Prone MRI Scans, Group Two: Supine MRI scans |
| Initial protocol MRI scanInitial scan to determine placement | Diagnostic test | Group One: Prone MRI Scans, Group Two: Supine MRI scans |
Primary outcome
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
Time frame: Through study completion, measurements completed at one day visit only.
Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- 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.
Eric A Hoffman, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prone hyperpolarized 3 helium gas scan, Supine hyperpolarized 3 helium gas scan and Vitals in people with Radiation Exposure, run by Eric A. Hoffman 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 1 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). 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?
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. (time frame: Through study completion, measurements completed at one day visit only.). 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 1 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.