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

NCT01710449 | Completed Phase 1

• 2 other identifiers: Pro00015170DIAL1001001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Lung Transplant

Outcome Measures

Primary Outcomes (1)

• MRI image quality of Perfluorinated Gas imaging of the lung

  Identify Image quality characteristics related to lung function characterized by 19F MRI.

  Single exposure

Study Arms (2)

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.

Drug: perfluorinated gas/oxygen mixture

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.

Drug: perfluorinated gas/oxygen mixture

Interventions

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.

Lung Disease; Normal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be ≥ 18 years of age;
• Evidence of lung disease or injury by medical history, physical exam, and/or clinical laboratories;
• COPD
• Asthma
• Cystic Fibrosis
• Emphysema/Other Small Airways Diseases
• Lung Transplant
• 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.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
• Unable to receive gas mixture by breathing because of contraindications;
• Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
• 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.
• 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
• 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:
• Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
• Unable to receive gas mixture by breathing because of contraindications;

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Cystic Fibrosis; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Cecil Charles, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Department of Radiology

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 9, 2013

Record last verified: 2013-11

Locations

US (1)