Clinical trial NCT03776747: Repeatability in Hyperpolarized 3-Helium With MRI
Official title: Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radiation Exposure
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
timeFrame: Through study completion, measurements completed at one day visit only.
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Eric A Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References: