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Repeatability in Hyperpolarized 3-Helium With MRI

Phase 4
Completed
Conditions
Radiation Exposure
Interventions
Drug: Supine hyperpolarized 3 helium gas scan
Drug: Prone hyperpolarized 3 helium gas scan
Diagnostic Test: Vitals
Diagnostic Test: Pulmonary Function Tests
Diagnostic Test: Initial protocol MRI scan
Registration Number
NCT03776747
Lead Sponsor
Eric A. Hoffman
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Group One: Prone MRI ScansVitalsSubjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Group One: Prone MRI ScansPulmonary Function TestsSubjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Group One: Prone MRI ScansInitial protocol MRI scanSubjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Group Two: Supine MRI scansSupine hyperpolarized 3 helium gas scanSubjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Group Two: Supine MRI scansVitalsSubjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Group One: Prone MRI ScansProne hyperpolarized 3 helium gas scanSubjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Group Two: Supine MRI scansPulmonary Function TestsSubjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Group Two: Supine MRI scansInitial protocol MRI scanSubjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Primary Outcome Measures
NameTimeMethod
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Iowa

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Iowa City, Iowa, United States

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