Repeatability in Hyperpolarized 3-Helium With MRI

Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Drug: Prone hyperpolarized 3 helium gas scan; Diagnostic test: Vitals; Diagnostic test: Pulmonary Function Tests; Diagnostic test: Initial protocol MRI scan; Drug: Supine hyperpolarized 3 helium gas scan

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group One: Prone MRI Scans; Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan	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.; Other Names: Prone MRI scan with contrast; 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
Active Comparator: Group Two: Supine MRI scans; Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan	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; 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.; Other Names: Supine MRI scan with contrast

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Eric A. Hoffman
• Investigators: Principal Investigator: Eric A Hoffman, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2008
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 200803776

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No