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Completed

NCT Number: NCT03776747

Repeatability in Hyperpolarized 3-Helium With MRI

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prone hyperpolarized 3 helium gas scan

Drug

Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.

Other names: Prone MRI scan with contrast

Supine hyperpolarized 3 helium gas scan

Drug

Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.

Other names: Supine MRI scan with contrast

Vitals

Diagnostic Test

Pulmonary function tests

Diagnostic Test

Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes

Initial protocol MRI scan

Diagnostic Test

Initial scan to determine placement

Primary outcomes

  1. Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eric A. Hoffman

Other

Registry information

Official study title

Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2018
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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