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Functional Applications of Hyperpolarized 129Xe MRI

This study has been terminated.
(Funding ended prior to resolution of all equipment (polarizer) issues.)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Samuel Patz, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01697332
First received: September 26, 2012
Last updated: December 28, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Hyperpolarized 129Xe gas
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Functional Applications of Hyperpolarized 129Xe MRI

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Baseline Statistics of Healthy Subjects [ Time Frame: At the end of a 4 year study. ]
    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. [ Time Frame: At the end of a 4 year study. ]
    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 [ Time Frame: At the end of a 4 year study. ]
    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.


Enrollment: 1
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with and without COPD
All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-80

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697332

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Samuel Patz, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Samuel Patz, Scientific Director, Center for Pulmonary Functional Imaging, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01697332     History of Changes
Other Study ID Numbers: Hyperpolarized xenon
5R01HL096471-04 ( US NIH Grant/Contract Award Number )
Study First Received: September 26, 2012
Last Updated: December 28, 2016

Keywords provided by Brigham and Women's Hospital:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 28, 2017