Pulmonary Surgical ProceduresPhase 3NCT03417687
Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection
A Phase 3 study testing 129Xe MRI and 133 Xe scintigraphy in people with Pulmonary Surgical Procedures, run by Polarean, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Surgical Procedures
- What is being tested?
- 129Xe MRI and 133 Xe scintigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Aug 2018to 10 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 years of age.
- Subject is being evaluated for possible lung resection (e.g., segmentectomy, lobectomy, or pneumonectomy).
- 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.
Who cannot join
- 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.
- 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.
- Subjects who have received any other investigational therapy within 4 weeks prior to Screening.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22908
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Duke University Hospital
Durham, North Carolina, 27710
About this study
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
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.
Read the 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
- Being tested
- 129Xe MRI, 133 Xe scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
129Xe MRIDrug
Also called 129Xenon scintigraphy
Evaluation of pulmonary function
133 Xe scintigraphyDrug
Also called 133Xenon scintigraphy
Evaluation of pulmonary function
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy Receives: Drug: 129Xe MRI; Drug: 133 Xe scintigraphy |
| Arm 2 | Active comparator | Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI Receives: Drug: 129Xe MRI; Drug: 133 Xe scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours
Secondary outcomes (7)
Predicted Versus Measured FEV1
The difference between the scan-predicted post-operative FEV1 and the measured post-operative FEV1
Measured: 3 months
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.
Measured: 48 hours
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.
Measured: 48 hours
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.
Measured: 48 hours
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.
Measured: 48 hours
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.
Measured: 48 hours
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start17 Aug 2018
- Primary completion31 Oct 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label crossover study
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polarean, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth P West, Study director, Polarean, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417687
- Sponsor's protocol ID
- POL-Xe-001
- Status last verified
- Jun 2022
- First submitted
- 25 Jan 2018
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03417687
- Acronym / sponsor ID
- POL-Xe-001
- Conditions
- Pulmonary Surgical Procedures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Polarean, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label crossover study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: 129Xe MRI, Drug: 133 Xe scintigraphySubjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy |
| Arm 2 | Active comparator | Drug: 129Xe MRI, Drug: 133 Xe scintigraphySubjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects ≥18 years of age.
- Subject is being evaluated for possible lung resection (e.g., segmentectomy, lobectomy, or pneumonectomy).
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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:
- Women who are lactating and insist on breast feeding.
- Subjects who have received any other investigational therapy within 4 weeks prior to Screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 129Xe MRIAlso: 129Xenon scintigraphyEvaluation of pulmonary function | Drug | Arm 1, Arm 2 |
| 133 Xe scintigraphyAlso: 133Xenon scintigraphyEvaluation of pulmonary function | Drug | Arm 1, Arm 2 |
Primary outcome
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).
7 secondary outcomes
Predicted Versus Measured FEV1
Time frame: 3 months
Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone.
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth P West study director
Polarean, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 129Xe MRI and 133 Xe scintigraphy in people with Pulmonary Surgical Procedures, run by Polarean, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicted Percentage of Remaining Pulmonary Function (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.