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Repeatability in Hyperpolarized 3-Helium With MRI

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ClinicalTrials.gov Identifier: NCT03776747
Recruitment Status : Active, not recruiting
First Posted : December 17, 2018
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eric A. Hoffman, University of Iowa

Brief 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.

Condition or disease Intervention/treatment Phase
Radiation Exposure Drug: Prone hyperpolarized 3 helium gas scan Drug: Supine hyperpolarized 3 helium gas scan Diagnostic Test: Vitals Diagnostic Test: Pulmonary Function Tests Diagnostic Test: Initial protocol MRI scan Phase 4

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:

  1. it allows us to see the microstucture of the lungs through diffusion imaging (apparent diffusion coefficient) which correlates with the size of airways and alveolar space.
  2. it allows us to see ventilation, or how air moves in the lungs, at a high resolution.
  3. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging
Actual Study Start Date : July 22, 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Drug: Prone hyperpolarized 3 helium gas scan
Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Other Name: Prone MRI scan with contrast

Diagnostic Test: Vitals
Diagnostic Test: Pulmonary Function Tests
Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes

Diagnostic Test: Initial protocol MRI scan
Initial scan to determine placement

Active Comparator: Group Two: Supine MRI scans
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Drug: Supine hyperpolarized 3 helium gas scan
Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
Other Name: Supine MRI scan with contrast

Diagnostic Test: Vitals
Diagnostic Test: Pulmonary Function Tests
Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes

Diagnostic Test: Initial protocol MRI scan
Initial scan to determine placement




Primary Outcome Measures :
  1. Apparent diffusion coefficient [ Time Frame: Through study completion, measurements completed at one day visit only. ]
    Lung volume inflation levels between left and right lungs



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be between the ages of 18 and 90
  • must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.

Exclusion Criteria:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03776747


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Eric A. Hoffman
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Eric A Hoffman, PhD University of Iowa

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Responsible Party: Eric A. Hoffman, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03776747     History of Changes
Other Study ID Numbers: 200803776
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No