Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Transplant

This is a multicenter, randomized, open-label, cross-over Phase 3 study evaluating
hyperpolarized 129Xe gas MRI as compared to 133Xe scintigraphy for the evaluation of
pulmonary function. This study will enroll subjects being evaluated for possible lung
transplant surgery (either single or bilateral) . Subjects will have both a 129Xe MRI and
133Xe scintigraphy image. The vast differences in technique for obtaining hyperpolarized
129Xe MRI as compared to 133Xe scintigraphy make it impossible to blind study procedures.
However, all image interpretation will be performed by personnel blinded to the subject's
medical history and all study assessments.

Inclusion Criteria:

1. Male or female subjects ≥18 years of age.

2. Subject is being evaluated for possible lung transplant surgery (either single or
bilateral).

3. Subject is able to undergo MRI imaging and able to fit in the MRI coil.

4. Subject is willing and able to comply with all study procedures.

5. Subject must understand and voluntarily sign an informed consent form (ICF) prior to
any study specific assessments or procedures.

Exclusion Criteria:

1. Baseline blood oxygen saturation (SpO2) <90% at rest. For subjects requiring routine
supplemental oxygen, SpO2 measurements should be taken with the patient's normal
oxygen supplementation.

2. Subjects that have undergone a prior pneumonectomy surgery to either lung.

3. Female subjects of childbearing potential with a positive serum pregnancy test at
screening, or who are not taking (or not willing to take) acceptable birth control
measures through the Follow-up Period. Adequate birth control methods include with a
monogamous partner who was sterilized more than 6 months prior to screening, or
measures with a Pearl index of <1 used consistently and correctly (including
intrauterine devices, or implantable, injectable, oral, or transdermal
contraceptives). Women are not considered to be of childbearing potential if they meet
at least 1 of the following 2 criteria as documented by the Investigator:

- They have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy
at a minimum of 1 menstrual cycle prior to signing the ICF; or

- They are post-menopausal: for women ≥55 years of age, defined as ≥1 year since
their last menstrual period, or for women <55 years of age, defined as ≥1 year
since their last menstrual period and have a follicle-stimulating hormone (FSH)
level in the laboratory's normal range for post-menopausal phase.

4. Women who are lactating and insist on breast feeding.

5. Have received any other investigational therapy within 4 weeks prior to Screening.

6. Requires anesthesia or heavy sedation to undergo MRI testing. Mild sedation could be
acceptable (i.e. a low dose oral acting anxiolytic medication such as alprazolam) as
long as, in the opinion of the investigator, the subject meets Inclusion Criteria #4
and #5.