Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Transplant

NCT03418090 | Completed Phase 3 FDA Drug

• 1 other identifier: POL-Xe-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Right lung function

  Scan predicted contribution of right lung to overall lung function

  48 hours

Secondary Outcomes (1)

• 6 zone analysis

  48 hours

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Drug: 129Xe MRI; Drug: 133XE scintigraphy

Arm 2

ACTIVE COMPARATOR

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

Drug: 129Xe MRI; Drug: 133XE scintigraphy

Interventions

129Xe MRI DRUG

Evaluation of pulmonary function

Also known as: 129Xenon MRI

Arm 1; Arm 2

133XE 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 transplant surgery (either single or bilateral).
• 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 subjects requiring routine supplemental oxygen, SpO2 measurements should be taken with the patient's normal oxygen supplementation.
• Subjects that have undergone a prior pneumonectomy surgery to either lung.
• 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.
• Have received any other investigational therapy within 4 weeks prior to Screening.

Sponsors & Collaborators

• Polarean, Inc.: lead

Study Sites (2)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Study Officials

• Kenneth P West

  Polarean, Inc.

  STUDY DIRECTOR

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: February 1, 2018
• Study Start: August 17, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (2)