Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 99 Years|
- - 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
Exclusion Criteria:- 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 1.
- - Unable to tolerate inhalation of the gas mixture - Unable to adequately complete other study measures, including spirometry and multiple breath nitrogen washout - 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 PI, would make the participant inappropriate for enrollment.
- - Pregnancy; women of childbearing potential must have a confirmed negative serum pregnancy test at screening, and a negative urine test on the day of the MRI scan, prior to the MRI scan (if serum test not performed the same day).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of North Carolina, Chapel Hill|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jennifer Goralski, MD|
|Principal Investigator Affiliation||University of North Carolina, Chapel Hill|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
The investigators hypothesize that 19F-enhanced MRI will detect improvements in lung ventilation following the treatment of a CF pulmonary exacerbation, and changes in ventilation as well as global MRI scores will track with both spirometry and quality of life assessments. Therefore, investigators propose this pilot and feasibility study to gain preliminary data on a comparison of the changes in ventilation that occur with treatment of a pulmonary exacerbation, as well as to begin to understand the repeatability of this novel outcome measure. Through this study, the investigators aim to: 1) Compare quantitative and qualitative assessments of lung ventilation using 19F MRI imaging and traditional, global physiologic assessments (spirometry, LCI) and compare these with images obtained in an age-matched healthy control population; 2) Correlate changes in MRI scoring with subjective changes in health related outcomes as measured by the CFQ-R (Cystic Fibrosis Questionnaire
- - Revised); 3) Determine the ability of 19F MRI to detect changes in ventilation that occur with treatment of a CF pulmonary exacerbation; and 4) Determine the repeatability of 19F MRI assessment of ventilation in a disease population.
Other: CF pulmonary exacerbation group
Patients with cystic fibrosis being treated for a pulmonary exacerbation will undergo Lung Clearance Index (LCI) and an MRI with PFP. LCI testing will take place before the MRI. Each test will take 5-20 minutes and up to three tests will be performed with at least 5-minute rest periods between each test. PFP gas will be administered using a full-face mask during the MRI. Images are acquired during 12-second breath-hold after every 3rd breath. Before and after the MRI is complete, participants will perform spirometry maneuvers in a room outside of the magnet.
Device: - Lung Clearance Index
To assess the efficiency of ventilation distribution and gas mixing by measuring the rate of clearance of an inert gas (nitrogen) from the lungs.
Drug: - MRI with PFP
Description: inhaled PFP, a gaseous contrast agent (79% PFP, 21% O2, pre-mixed, medical grade gas) Administration: Full-face disposable ventilation mask and a standard Douglas Bag system. Dosage: Two controlled breaths of contrast gas followed by a full breath and a 12-second breath-hold and scan for image acquisition. Frequency: Repeated 5 times followed by an identical five cycles with room air to ensure PFP gas wash-out has occurred.
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