Clinical trial NCT02734368: A Prospective, Cohort Study of Hyperpolarized 3He MRI in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Smoking-Induced Alterations in the Regional Alveolar Oxygen Tension Heterogeneity [Torr] in Smokers Compared to Healthy Controls and COPD Subjects
timeFrame: 2 years from baseline (+- 2 months)
measure: Smoking-Induced Alterations in the Apparent Diffusion Coefficient [cm^2/s] in Smokers Compared to Healthy Controls and COPD Subjects
timeFrame: 2 years from baseline (+- 2 months)
measure: Smoking-Induced Alterations in the Specific Ventilation [unitless] in Smokers Compared to Healthy Controls and COPD Subjects
timeFrame: 2 years from baseline (+- 2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Chaitanya R Divgi, MD
role: PRINCIPAL_INVESTIGATOR
References: