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Functional Applications of Hyperpolarized 129Xe MRI

This study is not yet open for participant recruitment.
Verified October 2012 by Brigham and Women's Hospital
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: October 1, 2012
Last verified: October 2012
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with and without COPD
All subjecs 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697332

Contacts
Contact: Iga Muradyan, PhD 617-278-0501 muradian@bwh.harvard.edu
Contact: Samuel Patz, PhD 617-278-0616 patz@bwh.harvard.edu

Locations
United States, Massachusetts
Brigham & Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Samuel Patz, PhD            
Sub-Investigator: Iga Muradyan, PhD            
Sub-Investigator: George Washko, MD            
Sub-Investigator: James P Butler, PhD            
Sub-Investigator: Ritu Gill, MD            
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

No publications provided

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, 5R01HL096471-03
Study First Received: September 26, 2012
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
COPD

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

ClinicalTrials.gov processed this record on May 16, 2013