Repeatability in Hyperpolarized 3-Helium With MRI

Eric A. Hoffman

Status and phase: Completed; Phase 4

Conditions: Radiation Exposure

Treatments: Diagnostic Test: Initial protocol MRI scan; Diagnostic Test: Pulmonary Function Tests; Drug: Supine hyperpolarized 3 helium gas scan; Diagnostic Test: Vitals; Drug: Prone hyperpolarized 3 helium gas scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03776747

200803776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Group One: Prone MRI Scans

Experimental group

Description:

Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan

Treatment:

Drug: Prone hyperpolarized 3 helium gas scan

Diagnostic Test: Pulmonary Function Tests

Diagnostic Test: Vitals

Diagnostic Test: Initial protocol MRI scan

Group Two: Supine MRI scans

Active Comparator group

Description:

Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan

Treatment:

Diagnostic Test: Pulmonary Function Tests

Diagnostic Test: Vitals

Drug: Supine hyperpolarized 3 helium gas scan

Diagnostic Test: Initial protocol MRI scan