Repeatability in Hyperpolarized 3-Helium With MRI

Radiation Exposure Clinical Trial

Official title:

Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776747
• Other study ID #: 200803776
• Status: Completed
• Phase: Phase 4
• Start date: July 22, 2008
• Est. completion date: June 2012

Study information

• Verified date: October 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

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.
• 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

• Pulmonary Function Tests
Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
• Initial protocol MRI scan
Initial scan to determine placement

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eric A. Hoffman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.