Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

Polarean

Status and phase: Completed; Phase 3

Conditions: Pulmonary Surgical Procedures

Treatments: Drug: 133 Xe scintigraphy; Drug: 129Xe MRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03417687

POL-Xe-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

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

Treatment:

Drug: 129Xe MRI

Drug: 133 Xe scintigraphy

Arm 2

Active Comparator group

Description:

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

Treatment:

Drug: 129Xe MRI

Drug: 133 Xe scintigraphy