Clinical trial: Study of Airflow in the Lungs Using Helium MRI (NCT02154568)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy subjects:

               -  Normal PFT values: FEV1 > 90% predicted; and Forced vital capacity (FVC) > 90%
                  predicted

               -  Normal chest x-ray (CXR)

               -  Medical history: No active pulmonary symptoms (cough, shortness of breath,
                  sputum); Negative history of pulmonary disease; Negative smoking history (never
                  smoked)

          -  Pulmonary Disease Subjects:

               -  PFT values: FEV1/FVC < 70% (indicative of obstruction); and 30% < FEV1 < 50%
                  predicted

               -  CXR normal except hyperinflation

               -  Symptoms - chronic shortness of breath

          -  All test subjects, healthy and with COPD should have similar physical anthropometric
             characteristics:

               -  Similar age with age difference less than 3 years

               -  Similar height (within 3-4 inches)

        Exclusion Criteria:

          -  Any condition for which a MRI procedure is contraindicated.

          -  Presence of any non-MRI compatible metallic material in the body, such as pacemakers,
             metallic clips, etc.

          -  Likelihood of claustrophobia

          -  Chest circumference greater than that of the helium MR coil.

          -  Pregnancy, by report of subject. Clinically in the Department of radiology at UVA,
             self report is used when screening patients for MR scans as well as CT scans and
             fluoroscopy studies. If the subject reports there is any chance of their being
             pregnant a urine pregnancy test will be performed prior to any imaging.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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