Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

NCT ID: NCT03417687

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-17
• Study Completion Date: 2020-03-10

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.

Conditions

Pulmonary Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: ACTIVE_COMPARATOR

129Xe MRI

Intervention Type: DRUG

Evaluation of pulmonary function

133 Xe scintigraphy

Intervention Type: DRUG

Evaluation of pulmonary function

Arm 2

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

Group Type: ACTIVE_COMPARATOR

129Xe MRI

Intervention Type: DRUG

Evaluation of pulmonary function

133 Xe scintigraphy

Intervention Type: DRUG

Evaluation of pulmonary function

Interventions

129Xe MRI

Evaluation of pulmonary function

Intervention Type: DRUG

133 Xe scintigraphy

Evaluation of pulmonary function

Intervention Type: DRUG

Other Intervention Names

129Xenon scintigraphy; 133Xenon scintigraphy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polarean, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth P West

Role: STUDY_DIRECTOR

Polarean, Inc.

Locations

Duke University Hospital

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

POL-Xe-001

Identifier Type: -

Identifier Source: org_study_id