Clinical trial NCT03417687: Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection
Official title: Evaluation of Hyperpolarized 129Xe MRI as Compared to 133Xe Scintigraphy for the Assessment of Pulmonary Function in Patients Being Evaluated for Possible Lung Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Surgical Procedures
Lead sponsor: Polarean, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open label crossover study
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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 resection surgery (i.e. segmentectomy, lobectomy, or pneumonectomy). 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.

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.

Primary outcomes:
measure: Predicted Percentage of Remaining Pulmonary Function
timeFrame: 48 hours
Secondary outcomes:
measure: Predicted Versus Measured FEV1
timeFrame: 3 months
measure: Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.
timeFrame: 48 hours
measure: Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.
timeFrame: 48 hours
measure: Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.
timeFrame: 48 hours
measure: Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.
timeFrame: 48 hours
measure: Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone.
timeFrame: 48 hours
measure: Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Polarean, Inc.
name: Kenneth P West
role: STUDY_DIRECTOR
References: