Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection
Condition: Pulmonary Surgical Procedures
Intervention: 129Xe MRI; 133 Xe scintigraphy
Intervention description: Evaluation of pulmonary function; Evaluation of pulmonary function
Intervention MeSH terms: Xenon
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open label crossover study
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe
      scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung
      resection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects ≥18 years of age.

          2. Subject is being evaluated for possible lung resection (e.g., segmentectomy,
             lobectomy, or pneumonectomy).

          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 patients requiring routine
             supplemental oxygen, SpO2 measurements should be taken with the patient's normal
             oxygen supplementation.

          2. 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.

          3. Women who are lactating and insist on breast feeding.

          4. Subjects who have received any other investigational therapy within 4 weeks prior to
             Screening.

          5. Subjects who require 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.