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Repeatability in Hyperpolarized 3-Helium With MRI

Sponsor
Eric A. Hoffman (Other)
Overall Status
Completed
CT.gov ID
NCT03776747
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
46.3
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 microstructure 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.

Study Design

Study Type:
Interventional
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 :
Jul 22, 2008
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Apparent diffusion coefficient [Through study completion, measurements completed at one day visit only.]

      Lung volume inflation levels between left and right lungs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Eric A. Hoffman

    Investigators

    • Principal Investigator: Eric A Hoffman, PhD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric A. Hoffman, Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT03776747
    Other Study ID Numbers:
    • 200803776
    First Posted:
    Dec 17, 2018
    Last Update Posted:
    Feb 15, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 15, 2021