Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

NCT03417687 | Completed Phase 3 Results FDA Drug

• 1 other identifier: POL-Xe-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Predicted Versus Measured FEV1

  3 months

• Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.

  48 hours

• Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.

  48 hours

• Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.

  48 hours

• Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.

  48 hours

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy

Drug: 129Xe MRI; Drug: 133 Xe scintigraphy

Arm 2

ACTIVE COMPARATOR

Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI

Drug: 129Xe MRI; Drug: 133 Xe scintigraphy

Interventions

129Xe MRI DRUG

Evaluation of pulmonary function

Also known as: 129Xenon scintigraphy

Arm 1; Arm 2

133 Xe scintigraphy DRUG

Evaluation of pulmonary function

Also known as: 133Xenon scintigraphy

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years of age.
• Subject is being evaluated for possible lung resection (e.g., segmentectomy, lobectomy, or pneumonectomy).
• Subject is able to undergo MRI imaging and able to fit in the MRI coil.
• Subject is willing and able to comply with all study procedures.
• Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study specific assessments or procedures.

You may not qualify if:

• 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.
• 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.
• Women who are lactating and insist on breast feeding.
• Subjects who have received any other investigational therapy within 4 weeks prior to Screening.

Sponsors & Collaborators

• Polarean, Inc.: lead

Study Sites (3)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Results Point of Contact

• Title: Laura Sutton
• Organization: Polarean

lsutton@polarean.com

919-206-7900

Study Officials

• Kenneth P West

  Polarean, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label crossover study

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: August 17, 2018
• Primary Completion: October 31, 2019
• Study Completion: March 10, 2020
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)