Back to resultsFunctional Applications of Hyperpolarized 129Xe MRI
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 129Xe gas
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
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
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with and without COPD
Arm Description
All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.
Outcomes
Primary Outcome Measures
Baseline Statistics of Healthy Subjects
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.
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.
Spatial Heterogeneity
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01697332
First Posted
September 26, 2012
Last Updated
March 19, 2018
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01697332
Brief Title
Functional Applications of Hyperpolarized 129Xe MRI
Official Title
Functional Applications of Hyperpolarized 129Xe MRI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Funding ended prior to resolution of all equipment (polarizer) issues.
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with and without COPD
Arm Type
Experimental
Arm Description
All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 129Xe gas
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Statistics of Healthy Subjects
Description
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.
Time Frame
4 years
Title
Differences Between Healthy and Diseased COPD Subjects.
Description
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.
Time Frame
4 years
Title
Spatial Heterogeneity
Description
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.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Patz, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional Applications of Hyperpolarized 129Xe MRI
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