Functional Applications of Hyperpolarized 129Xe MRI

Mass General Brigham

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Hyperpolarized 129Xe gas

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01697332

5R01HL096471-04 (U.S. NIH Grant/Contract)

2012P001947

Details and patient eligibility

About

The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease and its progression in COPD. We hypothesize that measurement of alveolar surface area, septal thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate better with quality of life measures in COPD subjects than traditional diagnostic measures such as spirometry and Computed Tomography.

Enrollment: 1 patient

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 20-75

For Healthy nonsmoker subjects:

• No current physician diagnosed medical disease requiring active medication
• No smoking history, defined as less than 100 cigarettes smoked in a lifetime
• Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted

For Subjects who have participated in the COPDGene Study

• Post-bronchodilator spirometry: FEV1 > 40% predicted

Exclusion criteria

• MR contraindications: e.g., electrical implants such as cardiac pacemakers, ferromagnetic implants such as prostheses, claustrophobia
• Pregnancy or suspected pregnancy
• Use of continuous oxygen
• Use of antibiotics and/or systemic corticosteroids (new prescription or increased dose) for an exacerbation of lung disease or any lung infection in the past four weeks
• Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy
• A heart attack in the past three months

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Subjects with and without COPD

Experimental group

Description:

All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.

Treatment:

Drug: Hyperpolarized 129Xe gas