Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01710449
• Date of registration: 17/10/2012
• Prospective Registration: No
• Primary sponsor: Hal C Charles
• Public title: Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen
• Scientific title: Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.
• Date of first enrolment: September 2009
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01710449
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, 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

Subjects with Lung and/or Airway Disease

-Inclusion Criteria

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;

1. COPD

2. Asthma

3. Cystic Fibrosis

4. Emphysema/Other Small Airways Diseases

5. 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

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 gas mixture by breathing because of contraindications;

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.

Normal Subjects

-Inclusion Criteria

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;

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

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 gas mixture by breathing because of contraindications;

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: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Asthma

Small Airways Diseases

COPD

Emphysema

Intervention(s)

Drug: perfluorinated gas/oxygen mixture

Primary Outcome(s)

MRI image quality of Perfluorinated Gas imaging of the lung [Time Frame: Single exposure]

Secondary ID(s)

Pro00015170

DIAL1001001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors