Clinical trial: 19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation (NCT03497117)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction