Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

University of Massachusetts, Worcester

Status: Terminated

Conditions: Healthy; Asthma; Cystic Fibrosis; COPD

Treatments: Drug: Hyperpolarized Helium-3

Study type: Interventional

Funder types: Other

Identifiers

NCT00846573

Docket # 12639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

Asthmatic Participants

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized Helium-3

Healthy

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized Helium-3

COPD Patients

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized Helium-3

Cystic Fibrosis Patients

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized Helium-3