New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 10/21/2017 |
| Start Date: | May 2016 |
| End Date: | June 2018 |
| Contact: | Rachel D Dieterich, RN |
| Email: | rdd8w@virginia.edu |
| Phone: | 434-243-6074 |
Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic
resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the
University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and
optimized for the equipment at UVA. These sequences will need to be evaluated in healthy
adults for comparison with results obtained and in adults with lung diseases to optimize the
sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to
be optimized for the parameters of a human MR coil and the gas exchange characteristics in
healthy and diseased lungs.
Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to
monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting
beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of
the current COPD therapeutics. The investigators will characterize the functional changes of
the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment
after a three-month trial. Also the investigators will compare corresponding results obtained
by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic
contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography
(HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators
anticipate that the results from this project will greatly improve the investigators
understanding of the lung functional responses of COPD subjects to current therapeutics.
Also, the investigators expect that this project will provide evidence to consider Xe129 MRI
as a diagnostic strategy to assess and monitor therapeutic responses of existing and new
pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in
the future
resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the
University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and
optimized for the equipment at UVA. These sequences will need to be evaluated in healthy
adults for comparison with results obtained and in adults with lung diseases to optimize the
sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to
be optimized for the parameters of a human MR coil and the gas exchange characteristics in
healthy and diseased lungs.
Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to
monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting
beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of
the current COPD therapeutics. The investigators will characterize the functional changes of
the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment
after a three-month trial. Also the investigators will compare corresponding results obtained
by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic
contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography
(HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators
anticipate that the results from this project will greatly improve the investigators
understanding of the lung functional responses of COPD subjects to current therapeutics.
Also, the investigators expect that this project will provide evidence to consider Xe129 MRI
as a diagnostic strategy to assess and monitor therapeutic responses of existing and new
pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in
the future
Inclusion Criteria:
- Subjects should be at their clinical baseline on the day of imaging
- Subjects must be clinically stable in order to participate in the study
- Smoking history >10 pack years
- Subjects must not be currently taking Advair or have taken it within 4 weeks prior to
screening
- No subject will be withdrawn from Advair to participate in this study
The subjects with COPD will be categorized according to the Global Initiative for Chronic
Obstructive Lung Disease (GOLD) COPD severity classification:
- Class 1: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) <
70 and FEV1 > 80% predicted;
- Class 2: FEV1/FVC < 70 and 50% < FEV1 < 80% predicted;
- Class 3: FEV1/FVC < 70 and 30% < FEV1 < 50% predicted;
- Class 4: FEV1/FVC < 70 and FEV1 < 30% predicted
Exclusion Criteria:
- Continuous oxygen use at home
- Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of
imaging
- FEV1 percent predicted less than 25%
- Pregnancy or lactation
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign
bodies in eye, pacemaker or other contraindication to MR scanning
- Subjects with any implanted device that cannot be verified as MRI compliant will be
excluded.
- Chest circumference greater than that of the xenon MR and/or helium coil. The
circumference of the coil is approximately 42 inches.
- History of congenital cardiac disease, chronic renal failure, or cirrhosis.
- Inability to understand simple instructions or to hold still for approximately 10
seconds.
- History of respiratory infection within 2 weeks prior to the MR scan
- History of myocardial infarction (MI) , stroke and/or poorly controlled hypertension.
- Known hypersensitivity to albuterol or any of its components, or levalbuterol
- Glomerular filtration rate (GFR) < 60 ml/min/1.73 m2 or known hypersensitivity to
Gd-contrast agents based on a serum creatinine drawn within 30 days of the MRI
- Acute kidney injury
- History of paraproteinemia syndromes such as multiple myeloma
- Hepatorenal syndrome
- Liver transplant
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Mike Shim, MD
Phone: 434-243-6074
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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