Functional Applications of Hyperpolarized 129Xe MRI

NCT ID: NCT01697332

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Subjects with and without COPD

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

Group Type: EXPERIMENTAL

Hyperpolarized 129Xe gas

Intervention Type: DRUG

800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.

Interventions

Hyperpolarized 129Xe gas

800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Samuel Patz

Scientific Director, Center for Pulmonary Functional Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Patz, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5R01HL096471-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012P001947

Identifier Type: -

Identifier Source: org_study_id