Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

Pulmonary Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417687
• Other study ID #: POL-Xe-001
• Status: Completed
• Phase: Phase 3
• Start date: August 17, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: June 2022
• Source: Polarean, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 10, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Surgical Procedures

Intervention

Drug:
• 129Xe MRI
Evaluation of pulmonary function
• 133 Xe scintigraphy
Evaluation of pulmonary function

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Polarean, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predicted Versus Measured FEV1	The difference between the scan-predicted post-operative FEV1 and the measured post-operative FEV1	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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