Repeatability in Hyperpolarized 3-Helium With MRI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging

Conditions
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Radiation Exposure

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group One: Prone MRI Scans<br>Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan | Drug: Prone hyperpolarized 3 helium gas scan<br>* Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.<br>* Other names: Prone MRI scan with contrast;Diagnostic Test: Vitals<br> <br> Diagnostic Test: Pulmonary Function Tests<br>* Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes<br>Diagnostic Test: Initial protocol MRI scan<br>* Initial scan to determine placement<br>|
| Active Comparator: Group Two: Supine MRI scans<br>Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan | Drug: Supine hyperpolarized 3 helium gas scan<br>* Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.<br>* Other names: Supine MRI scan with contrast;Diagnostic Test: Vitals<br> <br> Diagnostic Test: Pulmonary Function Tests<br>* Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes<br>Diagnostic Test: Initial protocol MRI scan<br>* Initial scan to determine placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, measurements completed at one day visit only. |