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| ID | Type | Description | Link |
|---|---|---|---|
| DIAL1001001 | Other Identifier | Duke University Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Experimental | 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. |
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| Lung Disease | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perfluorinated gas/oxygen mixture | Drug | Subjects are imaged with MRI one time in an proof of concept study for the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI image quality of Perfluorinated Gas imaging of the lung | Identify Image quality characteristics related to lung function characterized by 19F MRI. | Single exposure |
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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:
Subjects must be ≥ 18 years of age;
Evidence of lung disease or injury by medical history, physical exam, and/or clinical laboratories;
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Subjects who are willing and able to comply with scheduled visits and other trial procedures.
Subjects presenting with any of the following will not be included in the trial:
Normal Subjects
-Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Subjects must be ≥ 18 years of age;
Non-smokers;
No Evidence of prior lung disease or lung injury by medical history, physical exam, and/or clinical laboratories;
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Subjects who are willing and able to comply with scheduled visits and other trial procedures.
Subjects presenting with any of the following will not be included in the trial:
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| Name | Affiliation | Role |
|---|---|---|
| Cecil Charles, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D003550 | Cystic Fibrosis |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |