19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation
Stopped early · Early Phase 1
Conditions studied: Cystic Fibrosis
In brief
The purpose of this study is to use perfluorinated gas imaging to highlight regions of functional variation within the lungs of participants with cystic fibrosis (CF), and to correlate this with changes in spirometry, lung clearance index, and quality of life of CF subjects undergoing treatment for a pulmonary exacerbation.
Key facts
- Study ID
- NCT03497117
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 5
- Starts
- 2015-08-25
- Expected to finish
- 2019-09-13
- Last updated by the study team
- 2020-10-09
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Non-smokers (<10 pack year history and no active smoking in the past year);
- Diagnosis of cystic fibrosis via standard sweat chloride/phenotypic features/genotyping
- Able to reproducibly perform lung function testing and have an FEV1 >30% of predicted at screening.
- No requirement for supplemental oxygen
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- Participants must be willing and able to comply with scheduled visits and other trial procedures.
- Diagnosis of a pulmonary exacerbation according to Fuchs criteria (4 of the following 12 signs and symptoms) deemed to require antibiotic treatment, and must also include the change in lung function criterion:
- Change in sputum
- New or increased hemoptysis
- Increased cough
- Increased dyspnea
- Malaise, fatigue, or lethargy
- Temperature above 38deg C
- Anorexia or weight loss
- Sinus pain or tenderness
- Change in sinus discharge
- Change in physical examination of the chest
- Decrease in pulmonary function by 10% or more from a previously recorded value
- Radiographic change indicative of pulmonary infection
You may not qualify if…
- Under 18 years of age
- Active or former smokers with less than 1 years since quitting, or >10 pack-year smoking history
- Active asthma flare, as perceived by the study physician or unstable asthma characterized by advancement of asthma therapy in the last month or two courses of oral steroids in the past six months.
- Unable to undergo a 3.0-Tesla MRI of lungs and chest because of contraindications including
- Occupation (past or present) of machinist, welder, grinder
- Injury to the eye involving a metallic object
- Injury to the body by a metallic object (bullet, BB, shrapnel)
- Presence of a cardiac pacemaker or defibrillator
- Presence of aneurysm clips
- Presence of carotid artery vascular clamp
- Presence of neurostimulator
- Presence of insulin or infusion pump
- Presence of implanted drug infusion device that is not known to be MRI compatible (i.e., was placed outside of University of North Carolina Hospitals (UNCH) or is older than 10 years)
- Bone growth or fusion simulator
- Presence of cochlear, otologic or ear implant
- Any type of prosthesis (eye, penile, etc.)
- Artificial limb or joint
- Non-removable electrodes (on body, head or brain)
- Intravascular stents, filters or coils
- Shunt (spinal or intraventricular)
- Swan-Ganz catheter
- Any implant held in place by a magnet
- Transdermal delivery system (e.g. Nitro)
- Intrauterine device (IUD) or diaphragm
- Tattooed makeup (eyeliner, lips, etc.) or tattoos covering >25% of body surface area
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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