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

NCT02734368 | Terminated DMC

• 1 other identifier: COPD-807859
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• Smoking-Induced Alterations in the Regional Alveolar Oxygen Tension Heterogeneity [Torr] in Smokers Compared to Healthy Controls and COPD Subjects

  To measure the specificity and sensitivity of Regional Alveolar Oxygen Tension Heterogeneity in differentiation of healthy smokers from healthy nonsmokers and COPDs

  2 years from baseline (+- 2 months)

• Smoking-Induced Alterations in the Apparent Diffusion Coefficient [cm^2/s] in Smokers Compared to Healthy Controls and COPD Subjects

  To measure the specificity and sensitivity of Apparent Diffusion Coefficient in differentiation of healthy smokers from healthy nonsmokers and COPDs

  2 years from baseline (+- 2 months)

• Smoking-Induced Alterations in the Specific Ventilation [unitless] in Smokers Compared to Healthy Controls and COPD Subjects

  To measure the specificity and sensitivity of Specific Ventilation in differentiation of healthy smokers from healthy nonsmokers and COPDs

  2 years from baseline (+- 2 months)

Study Arms (3)

Healthy non-smokers

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

Drug: Hyperpolarized Helium-3

Asymptomatic smokers

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

Drug: Hyperpolarized Helium-3

COPD subjects

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

Drug: Hyperpolarized Helium-3

Interventions

Hyperpolarized Helium-3 DRUG

Asymptomatic smokers; COPD subjects; Healthy non-smokers

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chaitanya R Divgi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: April 12, 2016
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2015
• Last Updated: April 12, 2016

Record last verified: 2016-02

Locations

US (1)