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Trial record 1 of 1 for:    NCT03417687
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Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

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ClinicalTrials.gov Identifier: NCT03417687
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : June 28, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Surgical Procedures Drug: 129Xe MRI Drug: 133 Xe scintigraphy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open label crossover study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 17, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Active Comparator: Arm 1
Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy
Drug: 129Xe MRI
Evaluation of pulmonary function
Other Name: 129Xenon scintigraphy

Drug: 133 Xe scintigraphy
Evaluation of pulmonary function
Other Name: 133Xenon scintigraphy

Active Comparator: Arm 2
Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI
Drug: 129Xe MRI
Evaluation of pulmonary function
Other Name: 129Xenon scintigraphy

Drug: 133 Xe scintigraphy
Evaluation of pulmonary function
Other Name: 133Xenon scintigraphy




Primary Outcome Measures :
  1. Predicted Percentage of Remaining Pulmonary Function [ Time Frame: 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 :
  1. Predicted Versus Measured FEV1 [ Time Frame: 3 months ]
    The difference between the scan-predicted post-operative FEV1 and the measured post-operative FEV1

  2. Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone. [ Time Frame: 48 hours ]
    The fraction of total ventilation contributed by the lower left lung zone on 6-zone analysis.

  3. Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone. [ Time Frame: 48 hours ]
    The fraction of total ventilation contributed by the upper left lung zone on 6-zone analysis.

  4. Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone. [ Time Frame: 48 hours ]
    The fraction of total ventilation contributed by the middle left lung zone on 6-zone analysis.

  5. Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone. [ Time Frame: 48 hours ]
    The fraction of total ventilation contributed by the upper right lung zone on 6-zone analysis.

  6. Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone. [ Time Frame: 48 hours ]
    The fraction of total ventilation contributed by the middle right lung zone on 6-zone analysis.

  7. Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone. [ Time Frame: 48 hours ]
    The fraction of total ventilation contributed by the lower right lung zone on 6-zone analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417687


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Polarean, Inc.
Investigators
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Study Director: Kenneth P West Polarean, Inc.
  Study Documents (Full-Text)

Documents provided by Polarean, Inc.:
Study Protocol  [PDF] April 26, 2018
Statistical Analysis Plan  [PDF] June 2, 2020

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Responsible Party: Polarean, Inc.
ClinicalTrials.gov Identifier: NCT03417687    
Other Study ID Numbers: POL-Xe-001
First Posted: January 31, 2018    Key Record Dates
Results First Posted: June 28, 2022
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs