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

NCT ID: NCT02734368

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-03-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy non-smokers

Hyperpolarized Helium-3. Amounts adjusted based on subject's total lung capacity

Hyperpolarized Helium-3

Intervention Type: DRUG

Asymptomatic smokers

Hyperpolarized Helium-3. Amounts adjusted based on subject's total lung capacity

Hyperpolarized Helium-3

Intervention Type: DRUG

COPD subjects

Hyperpolarized Helium-3. Amounts adjusted based on subject's total lung capacity

Hyperpolarized Helium-3

Intervention Type: DRUG

Interventions

Hyperpolarized Helium-3

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chaitanya R Divgi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.med.upenn.edu/fmig/

Related Info

Other Identifiers

COPD-807859

Identifier Type: -

Identifier Source: org_study_id