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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Predicted Percentage of Remaining Pulmonary Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1
Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy
干预措施: 129Xe MRI (Drug)
Arm 1
Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy
干预措施: 133 Xe scintigraphy (Drug)
Arm 2
Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI
干预措施: 129Xe MRI (Drug)
Arm 2
Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI
干预措施: 133 Xe scintigraphy (Drug)
结局指标
主要结局
Predicted Percentage of Remaining Pulmonary Function
时间窗: 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).
次要结局
- Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.(48 hours)
- Predicted Versus Measured FEV1(3 months)
- Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.(48 hours)
- Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.(48 hours)
- Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.(48 hours)
- Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone.(48 hours)
- Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone.(48 hours)