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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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