Cystic Fibrosis Clinical Trial
Official title:
19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation
Verified date | October 2020 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | September 13, 2019 |
Est. primary completion date | September 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - 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. Occupation (past or present) of machinist, welder, grinder 2. Injury to the eye involving a metallic object 3. Injury to the body by a metallic object (bullet, BB, shrapnel) 4. Presence of a cardiac pacemaker or defibrillator 5. Presence of aneurysm clips 6. Presence of carotid artery vascular clamp 7. Presence of neurostimulator 8. Presence of insulin or infusion pump 9. 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) 10. Bone growth or fusion simulator 11. Presence of cochlear, otologic or ear implant 12. Any type of prosthesis (eye, penile, etc.) 13. Artificial limb or joint 14. Non-removable electrodes (on body, head or brain) 15. Intravascular stents, filters or coils 16. Shunt (spinal or intraventricular) 17. Swan-Ganz catheter 18. Any implant held in place by a magnet 19. Transdermal delivery system (e.g. Nitro) 20. Intrauterine device (IUD) or diaphragm 21. Tattooed makeup (eyeliner, lips, etc.) or tattoos covering >25% of body surface area 22. Body piercings (MUST BE REMOVED BEFORE MRI) 23. Any metal fragments 24. Internal pacing wires 25. Metal or wire mesh implants 26. Hearing aid (REMOVE BEFORE MRI) aa. Dentures (REMOVE BEFORE MRI) bb. Claustrophobia - 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). - Facial hair preventing a tight fit of the mask used in the study - Allergy or intolerance due to side effects to bronchodilators |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Couch MJ, Ball IK, Li T, Fox MS, Littlefield SL, Biman B, Albert MS. Pulmonary ultrashort echo time 19F MR imaging with inhaled fluorinated gas mixtures in healthy volunteers: feasibility. Radiology. 2013 Dec;269(3):903-9. doi: 10.1148/radiol.13130609. Epub 2013 Oct 28. — View Citation
Halaweish AF, Moon RE, Foster WM, Soher BJ, McAdams HP, MacFall JR, Ainslie MD, MacIntyre NR, Charles HC. Perfluoropropane gas as a magnetic resonance lung imaging contrast agent in humans. Chest. 2013 Oct;144(4):1300-1310. doi: 10.1378/chest.12-2597. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole lung ventilation defect volume (VDV) | To obtain ventilation defect volumes (VDVs), investigators will use the final wash-in image to identify all regions of interest having a signal intensity below the pre-defined threshold which indicates poor ventilation. The combined volume of all these 'ventilation defect' regions will be computed to obtain the VDV. | 1 day | |
Secondary | The wash-in kinetics of PFP | For each participant, an exponential model will be fit to obtain a statistical estimate, T, of the rate constant that characterizes the kinetics of gas wash-in. Aggregating across all participants, the frequency distributions of T values will be characterized by tabulating estimates of the mean and standard deviation (SD). Corresponding 95% confidence intervals and the minimum, maximum, and interquartile range of T values will also be tabulated. | 1 day | |
Secondary | Ventilation defect percent (VDP) correlation with LCI | Changes in VDP from pre/post treatment will be correlated with changes in LCI pre- and post-exacerbation. | 1 day | |
Secondary | Ventilation defect percent (VDP) correlation with FEV1 | Changes in VDP from pre/post treatment will be correlated with changes in FEV1 pre- and post- exacerbation. | 1 day |
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