Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Surgical Procedures
• Intervention / Treatment: Drug: 129Xe MRI; Drug: 133 Xe scintigraphy

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy	Drug: 129Xe MRI; Evaluation of pulmonary function; Other Names: 129Xenon scintigraphy; Drug: 133 Xe scintigraphy; Evaluation of pulmonary function; Other Names: 133Xenon scintigraphy
Active Comparator: Arm 2; Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI	Drug: 129Xe MRI; Evaluation of pulmonary function; Other Names: 129Xenon scintigraphy; Drug: 133 Xe scintigraphy; Evaluation of pulmonary function; Other Names: 133Xenon scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicted Percentage of Remaining Pulmonary Function	Predicted percentage of remaining pulmonary function is a pre-specified section of lung were to be removed. Investigators indicated which portions of lung were likely to be resected. Remaining percentage of pulmonary function was determined by subtracting the percentage of pulmonary function contributed by the planned zone of resection from the total pulmonary function using a standard 6-zone image analysis of the lung. The difference between predicted percentage of remaining pulmonary function was calculated by subtracting the value derived from the 133Xe scintigraphy image from the value derived from the 129Xe MRI image (e.g. 129Xe - 133Xe).	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicted Versus Measured FEV1	The difference between the scan-predicted post-operative FEV1 and the measured post-operative FEV1	3 months
Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.	The fraction of total ventilation contributed by the lower left lung zone on 6-zone analysis.	48 hours
Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.	The fraction of total ventilation contributed by the upper left lung zone on 6-zone analysis.	48 hours
Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.	The fraction of total ventilation contributed by the middle left lung zone on 6-zone analysis.	48 hours
Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.	The fraction of total ventilation contributed by the upper right lung zone on 6-zone analysis.	48 hours
Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone.	The fraction of total ventilation contributed by the middle right lung zone on 6-zone analysis.	48 hours
Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone.	The fraction of total ventilation contributed by the lower right lung zone on 6-zone analysis.	48 hours

Collaborators and Investigators

• Sponsor: Polarean, Inc.
• Investigators: Study Director: Kenneth P West, Polarean, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: POL-Xe-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No