Clinical trial NCT01731015: Imaging Lung Function Using Oxygen Enhanced MRI
Official title: A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Asthma
Cystic Fibrosis
Emphysema
Small Airways Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to allow an effect size estimate to power future studies.

Detailed description: This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air.

Objectives

* To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent.
* To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1

Eligibility criteria: Inclusion Criteria for Lung and/or Airway Disease

* Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Subjects must be ≥ 18 years of age;
  2. Evidence of lung disease or injury by medical history, physical exam, and/or clinical laboratories;

     * COPD
     * Asthma
     * Pre/Post Lung Transplant
     * Cystic Fibrosis
     * Emphysema/Other Small Airways Diseases
     * Lung Transplant
  3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
  4. Subjects who are willing and able to comply with scheduled visits and other trial procedures.

Exclusion Criteria for Subjects with Lung and/or Airway Disease:

Subjects presenting with any of the following will not be included in the trial:

1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
2. Unable to receive 100% oxygen by breathing because of potential hypercapnia ( SpO2 \<90% or FEV1 \< 1 L);
3. Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial. This determination is made by the referring physician based on standard clinical practice.
5. Female; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan.

Inclusion Criteria for Normal Subjects Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Subjects must be ≥ 18 years of age;
2. Non-smokers, ex-smokers with normal pulmonary function test by spirometry;
3. No Evidence of prior lung disease or lung injury by medical history, physical exam, and/or clinical laboratories;
4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
5. Subjects who are willing and able to comply with scheduled visits and other trial procedures.

Exclusion Criteria for Normal Subjects

Subjects presenting with any of the following will not be included in the trial:

1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
2. Unable to receive 100% oxygen by breathing because of potential hypercapnia (SpO2 \<90% or FEV1 \< 1 L) (Note, we consider this highly unlikely in a 'normal' subject);
3. Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
5. Female; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan.

Primary outcomes:
measure: Image Quality
timeFrame: one exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Cecil Charles, PhD
role: PRINCIPAL_INVESTIGATOR
References: