NCT03776747

Repeatability in Hyperpolarized 3-Helium With MRI

Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Eric A. Hoffman · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Radiation Exposure

Interventions

Type	Name	Description
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.
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.
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

Timeline

• Start date: 2008-07-22
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2018-12-17
• Last updated: 2023-11-01
• Results posted: 2023-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study