Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Transplant

Phase 3

Completed

• Conditions: Pulmonary Surgical Procedures
• Interventions: Drug: 129Xe MRI; Drug: 133XE scintigraphy

• Registration Number: NCT03418090
• Lead Sponsor: Polarean, Inc.

Brief Summary

This study compares the equivalence of hyperpolarized 129Xe MRI to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung transplant.

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 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.

Study Timeline

• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Study Start: 2018-08-17
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 2	129Xe MRI	Subjects will first undergo 133Xe scintigraphy followed by hyperpolarized 129Xe MRI
Arm 1	133XE scintigraphy	Subjects will first undergo hyperpolarized 129Xe MRI followed by 133Xe scintigraphy
Arm 2	133XE scintigraphy	Subjects will first undergo 133Xe scintigraphy followed by hyperpolarized 129Xe MRI
Arm 1	129Xe MRI	Subjects will first undergo hyperpolarized 129Xe MRI followed by 133Xe scintigraphy

Primary Outcome Measures

Name	Time	Method
Right lung function	48 hours	Scan predicted contribution of right lung to overall lung function

Secondary Outcome Measures

Name	Time	Method
6 zone analysis	48 hours	The percentage function contributed by each of the individual 6 lung zones.

Trial Locations

Locations (2)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States