Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation Using the Philips MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical determination whether the sequence improves patient care during MRI-guided procedures.
研究概览
简要总结
The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.
详细描述
This proposal includes evaluation of advanced MR imaging methods in the iMRI environment and will operate within the NSR guidelines for data acquisition established by the FDA/CDRH. The significant testing by vendor and Mayo staff prior to in vivo use, assure the safety of these studies and overall system stability.
The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Male or female.
- •Age ≥ 18 years.
- •Healthy volunteers or patients already scheduled for a MR-guided procedure.
排除标准
- •Individuals 18 years of age.
- •Pregnant women.
研究组 & 干预措施
Healthy Volunteers
Imaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Patients receiving MRI-guided procedures
As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
结局指标
主要结局
Clinical determination whether the sequence improves patient care during MRI-guided procedures.
时间窗: 3 years
It will be determined whether the sequence under investigation improves one of the following: 1. lesion targeting (e.g. better guidance of applicators by reduction of metal artifact), 2. lesion ablation (e.g. improved MR thermometry, visualization of cryoablation ice), or 3. accurate assessment of treatment outcome (e.g. margins of ablation relative to lesion boundaries.
次要结局
未报告次要终点