Functional Applications of Hyperpolarized 129Xe MRI

Phase 1

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Hyperpolarized 129Xe gas

• Registration Number: NCT01697332
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-02
• Study Start: 2013-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-03
• Results First Submitted: 2018-03-19
• Results First Submitted QC: 2018-03-19
• Last Update Submitted: 2018-03-19
• Results First Posted: 2018-04-17
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with and without COPD	Hyperpolarized 129Xe gas	All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.

Primary Outcome Measures

Name	Time	Method
Spatial Heterogeneity	4 years	Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.
Baseline Statistics of Healthy Subjects	4 years	Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.
Differences Between Healthy and Diseased COPD Subjects.	4 years	Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.

Trial Locations

Locations (1)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States