Functional Applications of Hyperpolarized 129Xe MRI

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Functional Applications of Hyperpolarized 129Xe MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01697332
• Other study ID #: 2012P001947
• Secondary ID: 5R01HL096471-04
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 26, 2012
• Last updated: March 19, 2018
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years
Primary	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.	4 years
Primary	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.	4 years