Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
2018年4月28日 更新者：Pejman Ghanouni
A Feasibility Study to Evaluate the Safety and Effectiveness of ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound Treatment of Soft Tissue Tumors of the Extremities
The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.
研究概览
详细说明
Given that the incidence of cancer increases with age, the number of elderly patients diagnosed and treated for soft tissue sarcomas (STS) will increase.
The dilemma is that surgeons and medical oncologists may be hesitant to treat elderly patients in a comparably intensive manner as is used in the treatment of younger patients; factors such as decreased performance status, significant comorbidities, and disease natural history may erode enthusiasm for aggressive STS resection.
To this end, a less invasive way of treating soft tissue tumors would be helpful in younger patients to minimize morbidity and in the elderly to provide less aggressive treatment options.
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue (5-10).
The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T or 3 T MRI scanner.
It provides a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control.
研究类型
介入性
注册 (实际的)
5
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Stanford、California、美国、94305
- Stanford University School of Medicine
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
INCLUSION CRITERIA
- ≥ 10 years of age.
- Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
- Tumor must not have been treated previously with radiation.
- Targeted tumor(s) are accessible to the ExAblate device
- Targeted volume within the tumor is located deeper than 1 cm from the skin
- Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)
- Karnofsky Performance Status > 60
- Normal platelet count and coagulation profile
- Glomerular filtration rate > 60 mL/min
- Able to safely undergo MRI exam and receive mild sedation for the treatment.
- Able to tolerate being in the MRI scanner for the duration of the study.
- Able and willing to give consent (or consent + assent where applicable), and able to attend all study visits.
EXCLUSION CRITERIA
- Previous radiation treatment to the tumor.
- Currently receiving dialysis.
- Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study
Unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
- Contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc
- Severe hematologic, neurologic, or other uncontrolled disease
- Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
- Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
- Pregnant and nursing
- Karnofsky Performance Score < 60
- Severe cerebrovascular disease [cardiovascular accident (CVA) within 6 months]
- Not able or not willing to tolerate the required prolonged stationary position during treatment (up to 5 hrs of total table time)
- Target volume in tumor is less than 1 cm from neurovascular bundles, major blood vessels, bowel, or bladder.
Targeted tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Not a candidate for either regional anesthesia or mild sedation
- Not be participating in another trial testing other investigational agents or devices
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MRgHIFU
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue.
The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours.
The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time.
MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment.
The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated.
About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
|
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue
其他名称：
325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
其他名称：
40 mg by subcutaneous (SC) administration, for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Safety - Incidence of Any Device-related Adverse Events
大体时间：1 week
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Safety determined by evaluating for the incidence of any device-related adverse events.
Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment.
Safety is reported as the total incidence of device-related adverse events.
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1 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse Event Severity
大体时间：6 months
|
Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades. CTCAE Severity:
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6 months
|
|
Percent Successful Tumor Ablation
大体时间：Up to 1 week
|
In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice.
The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed.
Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.
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Up to 1 week
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pejman Ghanouni, MD, PhD、Stanford University
- 首席研究员：Raffi Avedian, MD、Stanford University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2015年3月24日
研究完成 (实际的)
2015年3月24日
研究注册日期
首次提交
2013年10月15日
首先提交符合 QC 标准的
2013年10月15日
首次发布 (估计)
2013年10月17日
研究记录更新
最后更新发布 (实际的)
2018年5月23日
上次提交的符合 QC 标准的更新
2018年4月28日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.