A Prospective, Cohort Study of Hyperpolarized 3He MRI in Chronic Obstructive Pulmonary Disease
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | February 2010 |
| End Date: | March 2015 |
The purpose of this study is to determine the MRI characteristics of Chronic Obstructive
Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to
correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and
respiratory questionnaires.
The central hypothesis is that quantitative assessment of the lung through magnetic
resonance imaging of hyperpolarized 3He can detect early alterations in structure and
function which are precursors to clinically apparent COPD and that these precursors can be
used to predict progression of disease earlier and better than established clinical methods.
Novel assessments using 3He MRI will lead to new information about COPD and will be critical
for characterizing disease response to therapy. A secondary hypothesis is that a variety of
technical improvements in the techniques of hyperpolarized gas MRI will accelerate the
translation of this relatively new modality to clinical use.
Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to
correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and
respiratory questionnaires.
The central hypothesis is that quantitative assessment of the lung through magnetic
resonance imaging of hyperpolarized 3He can detect early alterations in structure and
function which are precursors to clinically apparent COPD and that these precursors can be
used to predict progression of disease earlier and better than established clinical methods.
Novel assessments using 3He MRI will lead to new information about COPD and will be critical
for characterizing disease response to therapy. A secondary hypothesis is that a variety of
technical improvements in the techniques of hyperpolarized gas MRI will accelerate the
translation of this relatively new modality to clinical use.
Inclusion Criteria:
- Written informed consent was obtained and documented (after the investigator has
given oral and written information about the study to the subject).
- The subject was conscious, co-operative, and agreed to return for the scheduled
visits and tests and any visits required to obtain additional safety information.
- The subject's medical history, physical examination (including vital signs, pulse
oximetry, PFT's, and 12-lead electrocardiogram [ECG]), and clinical laboratory tests
(hematology, serum chemistry) obtained at the screening visit were within acceptable
limits for entry into the study, as judged by the investigator.
Exclusion Criteria:
- Subject is <40 or >70 years old
- Subject known to be pregnant
- Subject with a baseline oxygen requirement > 2 l/min via nasal cannula
- Any known contraindication to MRI examination
- Inability to provide informed consent
- A language, communication, cognitive or behavioral impairment that might interfere
with fully informed consent
- Active drug or alcohol dependence
- Homelessness or other unstable living situation
- Active drug or alcohol dependence
- Significant co-morbidities such as heart disease, kidney disease, liver disease,
hematologic or neurological disease that require continuing treatment.
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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