Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Transplant

• ClinicalTrials.gov Identifier: NCT03418090
• Recruitment Status: Completed
• First Posted: February 1, 2018
• Last Update Posted: January 28, 2020
• Sponsor: Polarean, Inc.
• Information provided by (Responsible Party): Polarean, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Surgical Procedures	Drug: 129Xe MRI; Drug: 133XE scintigraphy	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Open label crossover study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Transplant Surgery
• Actual Study Start Date: August 17, 2018
• Actual Primary Completion Date: November 4, 2019
• Actual Study Completion Date: November 4, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm 1; Subjects will first undergo hyperpolarized 129Xe MRI followed by 133Xe scintigraphy	Drug: 129Xe MRI; Evaluation of pulmonary function; Other Name: 129Xenon MRI; Drug: 133XE scintigraphy; Evaluation of pulmonary function; Other Name: 133Xenon scintigraphy
Active Comparator: Arm 2; Subjects will first undergo 133Xe scintigraphy followed by hyperpolarized 129Xe MRI	Drug: 129Xe MRI; Evaluation of pulmonary function; Other Name: 129Xenon MRI; Drug: 133XE scintigraphy; Evaluation of pulmonary function; Other Name: 133Xenon scintigraphy

Outcome Measures

Primary Outcome Measures :

1. Right lung function [ Time Frame: 48 hours ]
   Scan predicted contribution of right lung to overall lung function

Secondary Outcome Measures :

1. 6 zone analysis [ Time Frame: 48 hours ]
   The percentage function contributed by each of the individual 6 lung zones.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Duke University Hospital

Durham, North Carolina, United States, 27710

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Polarean, Inc.

Investigators

• Study Director: Kenneth P West; Polarean, Inc.

More Information

• Responsible Party: Polarean, Inc.
• ClinicalTrials.gov Identifier: NCT03418090
• Other Study ID Numbers: POL-Xe-002
• First Posted: February 1, 2018
• Last Update Posted: January 28, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Xenon; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs