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

Hal C Charles

Status and phase: Completed; Phase 1

Conditions: Small Airways Diseases; Asthma; Emphysema; Cystic Fibrosis; COPD

Treatments: Drug: perfluorinated gas/oxygen mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT01710449

DIAL1001001 (Other Identifier)

Pro00015170

Details and patient eligibility

About

An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal controls. Each subject will receive PFP as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.

Full description

The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gas mixed with oxygen as an exogenous inert contrast agent to image the airway spaces in normal and diseased human lungs. This is an open label proof of concept study expanding on work by other groups in animals and ex-vivo human lungs and on studies in human subjects with such gases. Projection images (2-dimensional) and 3D images will be obtained using 19F MRI coupled with spirometry breathing maneuvers to correlate spirometry variables (e.g. FEV1 and FEV1/FVC) with regional distribution of the gas.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

Normal

Experimental group

Description:

The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.

Treatment:

Drug: perfluorinated gas/oxygen mixture

Lung Disease

Experimental group

Description:

The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.

Treatment:

Drug: perfluorinated gas/oxygen mixture