A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Total frequency and severity of adverse events
研究概览
简要总结
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.
详细描述
Primary Objective: The primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation.
Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Men and women ≥ 18 years of age
- •Patients willing to sign a written informed consent document
- •Patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma
- •Patients with upper abdominal pain rating at least 4 out of 10 in severity on BPI
- •Tumor must be visualized on CT or MRI, obtained within 30 days of enrollment
- •Tumor must be accessible to the ExAblate MRgFUS device
- •Life expectancy ≥ 3 months, as determined by oncologist and documented in chart
- •ECOG performance status of 0, 1, or 2
- •INR < 1.6, platelet count > 50,000 microL
- •Serum urate, calcium, potassium, phosphate, creatinine < 1.5x upper limit of normal
- •Patients can receive general anesthesia, as determined by anesthesiologist
排除标准
- •Previous pancreatic surgery
- •Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia, etc.
- •Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis
- •Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- •Patients unable to receive general anesthesia
- •Target is:
- •NOT visible by non-contrast MRI, OR
- •NOT accessible to ExAblate device
- •Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 6 hrs of total table time)
- •Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
- •Patients with 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
- •Patients with severe hypertension (diastolic BP > 100 on medication)
- •Patients with severe hematologic, neurologic, or other uncontrolled disease (e.g. platelets < 50,000/microL, INR > 1.5)
- •Patients who are taking anti-thrombotic medication
- •Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)
结局指标
主要结局
Total frequency and severity of adverse events
时间窗: 24 months
Safety of ablation, as measured by the total frequency and severity of adverse events. Adverse events will be categorized and grade for severity according to the Common Terminology Criteria for Adverse Events, Version 5.0. Ablation will be deemed safe if there are no treatment-related serious adverse events, and no more than five moderate or mild treatment-related adverse events, among the ten patients during follow up.
Measure acceptable ablation percentage
时间窗: Immediately after MRgFUS treatment
Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage. Acceptable ablation percentage is defined as ≥50% of the targeted volume appearing ablated on post-treatment imaging. Ablation will be deemed feasible if at least seven of the ten patients have an acceptable ablation percentage
次要结局
- Assess Pain Response assessed by morphine equivalent daily dose (MEDD)(Baseline, 1 week, and monthly for 24 months following treatment)
- Evidence of ablation-induced inflammation(1week)
- Assess Pain Response assessed by the Brief Pain Inventory (BPI)(Baseline, 1 week, and monthly for 24 months following treatment)