Imaging Regional Lung Defect Severity

• Status: Completed
• Trial end date: 2018-08-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to develop and evaluate the usefulness of magnetic resonance imaging (MRI) using inert perfluorinated gases mixed with oxygen for regional assessment of pulmonary function. The proposed study seeks to determine regional qualitative and quantitative lung function information in the context of the clinical trajectory of chronic obstructive pulmonary disease (COPD) defined by the cross sectional cohort component. In the case of these perfluorinated (PFx)/oxygen mixtures, the availability of multi-liter quantities allows for wash-in/wash-out image acquisition and analysis allowing direct measures of gas trapping in a manner not easily achieved with any existing modality.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hal C Charles

Criteria

COPD Subjects: All subjects will be adults (age >18) with spirometrically confirmed COPD (GOLD stages I-IV) recruited from the greater Durham, North Carolina community. We anticipate 52% female and 14% minority based on community demographics and previous COPD study recruitment (see below). No subject will be excluded from the study on the basis of gender or ethnicity. Female subjects of childbearing potential will undergo pregnancy testing at study entry, and before each procedure. Informed consent will be obtained before a subject begins any study.

Definition of COPD: We will define COPD in accordance with the World Health Organization definition as a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. Furthermore, we will classify COPD severity using post bronchodilator GOLD spirometry criteria:

forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.70 and Mild (GOLD I): FEV1 >80% predicted Moderate (GOLD II): FEV1 50-80% predicted Severe (GOLD III): FEV1 30-50% predicted Very Severe (GOLD IV): FEV1 <30% predicted

Inclusion criteria,

• Outpatients of either gender, age > 18.

• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)

• Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.

• Clinical diagnosis of COPD confirmed by spirometry demonstrating FEV1/FVC < 0.70

Exclusion criteria

• Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids

• Abuse of alcohol or illicit substances

• Medical conditions, which, in the opinion of the investigator, will significantly affect five-year survival.

• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

• Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine, renal insufficiency with epidermal growth factor receptor (eGFR) < 60 mL/min/1.73 m2)

Continued therapy with the patient's prescribed COPD regimen will be permitted. Similarly, all other prescribed medications will be allowed.

Normal Subjects: All subjects will be adults (age >18) with normal pulmonary function tests (spirometrically confirmed) recruited from the greater Durham, North Carolina community. We anticipate 52% female and 14% minority based on community demographics (see below). No subject will be excluded from the study on the basis of gender or ethnicity. Female subjects of childbearing potential will undergo pregnancy testing at study entry, and before each procedure. Informed consent will be obtained before a subject begins any study.

Inclusion criteria,

• Outpatients of either gender, age > 18.

• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)

• Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.

• Normal pulmonary function testing (PFT) determined by spirometry.

Exclusion criteria

• Abuse of alcohol or illicit substances

• Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)