Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

Healthy Clinical Trial

Official title:

Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00846573
• Other study ID #: Docket # 12639
• Status: Terminated
• Phase: N/A
• First received: February 16, 2009
• Last updated: November 8, 2012
• Start date: November 2008
• Est. completion date: April 2011

Study information

• Verified date: November 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.

Description:

Current pulmonary imaging techniques are clinically regulated to machines that produce radiation. MR which does not produce radiation was not possible due to the low concentration of fluids in the open spaces of the lungs. With hyperpolarized noble gases we can now use the safe techniques of MR imaging to view the airways of the lungs, thus limiting human exposure to radiation. This technique has already been proven to be possible in human subjects but there is insufficient data show its efficacy in a clinical setting. This study is designed to image a variety of pulmonary disorders to better find possible clinical uses for hyperpolarized gas MRI.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Are male or female and are 5 years or older

• Consent/assent from the patient

• Have been diagnosed with a pulmonary disease such as COPD, Asthma, or cystic fibrosis. OR Healthy Individuals.

• Must be able to hold their breath for up to 15 seconds

Exclusion Criteria:

• Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;

• Are undergoing the MR exam in an emergency situation

• Are pregnant or become pregnant at any point within the study time.

• People with psychiatric disorders will be excluded from the study.

• Are claustrophobic and can not tolerate the imaging.

• Uses supplemental oxygen

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis
• Healthy
• Lung Diseases

Intervention

Drug:
• Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.

Locations

Country	Name	City	State
United States	UMASS Medical School Advanced MRI Center United States	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperpolarized Helium-3 MR Images	We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.	15 second breath-hold	No