A Prospective, Cohort Study of Hyperpolarized 3He MRI in Chronic Obstructive Pulmonary Disease

University of Pennsylvania

Status

Terminated

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Hyperpolarized Helium-3

Study type

Observational

Funder types

Other

Identifiers

NCT02734368

COPD-807859

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.