Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

Phase 3

Completed

• Conditions: Pulmonary Surgical Procedures
• Interventions: Drug: 129Xe MRI; Drug: 133 Xe scintigraphy

• Registration Number: NCT03417687
• Lead Sponsor: Polarean, Inc.

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.

Study Timeline

• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-31
• Study Start: 2018-08-17
• Primary Completion: 2019-10-31
• Study Completion: 2020-03-10
• Results First Submitted: 2022-04-27
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Results First Posted: 2022-06-28
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	133 Xe scintigraphy	Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy
Arm 2	129Xe MRI	Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI
Arm 2	133 Xe scintigraphy	Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI
Arm 1	129Xe MRI	Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy

Primary Outcome Measures

Name	Time	Method
Predicted Percentage of Remaining Pulmonary Function	48 hours	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).

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States