Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

NCT ID: NCT00846573

Last Updated: 2012-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-04-30

Brief 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.

Detailed 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.

Conditions

COPD; Cystic Fibrosis; Asthma; Healthy

Keywords

Helium; MRI; Hyperpolarized Helium; Hyperpolarized Noble Gas

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Asthmatic Participants

This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants 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.

Group Type: EXPERIMENTAL

Hyperpolarized Helium-3

Intervention Type: DRUG

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.

Healthy

This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.

Participants will inhale Hyperpolarized Helium-3: Participants 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.

Group Type: EXPERIMENTAL

Hyperpolarized Helium-3

Intervention Type: DRUG

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.

COPD Patients

This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.

Participants will inhale Hyperpolarized Helium-3: Participants 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.

Group Type: EXPERIMENTAL

Hyperpolarized Helium-3

Intervention Type: DRUG

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.

Cystic Fibrosis Patients

This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.

Participants will inhale Hyperpolarized Helium-3: Participants 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.

Group Type: EXPERIMENTAL

Hyperpolarized Helium-3

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

HP 3He

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Mitchell Albert

Director of Advanced MRI Center, UMASS Medical Sch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitchell S Albert, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UMASS Medical School

Locations

UMASS Medical School Advanced MRI Center United States

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

Docket # 12639

Identifier Type: -

Identifier Source: org_study_id