Imaging Lung Function Using Oxygen Enhanced MRI

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01731015
• Date of registration: 16/11/2012
• Prospective Registration: No
• Primary sponsor: Hal C Charles
• Public title: Imaging Lung Function Using Oxygen Enhanced MRI
• Scientific 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
• Date of first enrolment: January 2012
• Target sample size: 15
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01731015
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Cecil Charles, PhD
• Affiliation: Duke University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

COPD

Cystic Fibrosis

Emphysema

Small Airways Disease

Asthma

Intervention(s)

Drug: Medical Grade Oxygen

Primary Outcome(s)

Image Quality [Time Frame: one exposure]

Secondary ID(s)

DIAL1001002

Pro00024828

Source(s) of Monetary Support

Please refer to primary and secondary sponsors