NCT06487013招募中不适用
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
EpiSonica4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Pain response rate to therapy at 30 days after treatment
研究概览
简要总结
A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
详细描述
Pain palliation of bone metastasis through localized denervation by thermal ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Provisional Screening (Screening 1):
- •Men and women aged 18 and older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment.
- •Patients who are able and willing to give consent and able to attend all study visits.
- •Patients who are suffering from painful bone metastases.
- •Patients who refuse other accepted available treatments such as surgery or radiotherapy for pain palliation.
- •Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
- •Able to communicate sensations during the ArcBlate MRgHIFU treatment.
- •Patients on ongoing systemic anticancer treatment for at least 2 weeks before treatment:
- •with same systemic anticancer treatment (as documented from patient medical dossier), And
- •worst pain NRS still ≥ 4, And
- •do NOT plan to initiate a new chemotherapy for pain palliation throughout the study duration.
- •(9) No radiation therapy to targeted (most painful) lesion in the past two weeks before treatment.
- •(10) Bisphosphonate intake should remain stable throughout the study duration. (11) Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.
- •(12) Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site to be treated).
- •MRI Screening (Screening 2):
- •Targeted tumor(s) are ArcBlate MRgHIFU accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5).
- •Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
- •Targeted (treated) tumor clearly visible by non-contrast MRI, and ArcBlate MRgHIFU accessible.
- •Sonication Screening (Screening 3):
- •Subjects could tolerate planned test sonications per randomized treatment.
排除标准
- •Provisional Screening (Screening 1):
- •(1) Patients who either
- •need surgical stabilization of the affected bony structure (>7 fracture risk score), Or
- •targeted tumor is at an impending fracture site (>7 on fracture risk score), Or
- •patients with surgical stabilization of tumor site with metallic hardware. (2) Targeted (treated) lesion is in the skull. (3) Patients on dialysis. (4) Patients with life expectancy < 3-Months. (5) Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- •(6) 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. (7) Severe hypertension (diastolic blood pressure > 100 mmHg on medication). (8) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (unable to fit into ArcBlate MRgHIFU), etc.
- •(9) Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- •(10) Known intolerance or allergies to the MRI contrast agent (e.g., Gadolinium or Magnevist) and Computed Tomography (CT) contrast agent including advanced kidney disease.
- •(11) Severe cerebrovascular disease (multiple CerebroVascular Accident (CVA) or CVA within 6 months).
- •(12) Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.).
- •(13) Are participating or have participated in another clinical trial in the last 30 days.
- •(14) Patients initiating a new chemotherapy regime, or radiation (for the targeted most painful lesion) within the last 2 weeks before treatment.
- •(15) Patients unable to communicate with the investigator and staff. (16) Patients with persistent undistinguishable pain (pain source unidentifiable).
- •(17) The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.
- •(18) Patients with calcified treatment area. (19) Pregnant women.
- •MRI Screening (Screening 2):
- •Target (treated) lesion is less than 10-mm from nerve bundles, bowels or bladder.
- •Extensive scarring in the energy path of the planned treatment area
研究组 & 干预措施
MRgHIFU treatment arm
Experimental
Subjects will be randomized to MRgHIFU treatment arm and will pass the Screening Fail criteria preceded in normal fashion to MRgHIFU treatment at the same session.
干预措施: ArcBlate Focused Ultrasound Ablation System (Device)
Sham treatment arm
Sham Comparator
Subjects who will be randomized to sham treatment arm and passed the Screening Fail Criteria (i.e. MRI Screening and Sonication Screening) will undergo a sham MRgHIFU treatment with sonication energy disabled.
干预措施: Sham MRgHIFU treatment (Other)
结局指标
主要结局
Pain response rate to therapy at 30 days after treatment
时间窗: at 30 days after treatment
Pain response rate is assessed by composite endpoint of change from baseline in worst Numerical Rating Scale (NRS) pain score (0-10 scale) and morphine equivalent daily dose (MEDD) intake. Patients with Complete response (CR) or Partial response (PR) are defined as responders to therapy. 1. Complete response (CR): Pain score 0 without analgesic increase. 2. Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase. The proportion of responders of the subjects who completed treatment is defined as the pain response rate of this study.
次要结局
- Total number of Adverse Events (AEs)(within the first 90 days within treatment)
- Change from baseline in MEDD intake(at 7, 14, 30, 60 and 90 days after treatment)
- Pain response rate to therapy(at 60 and 90 days after treatment)
- Change from baseline in NRS pain score (0-10 scale)(at 1, 3, 7, 14, 30, 60 and 90 days after treatment)
- Quality of Life as measured by EORTC QLQ-C15-PAL questionnaire(at 30, 60 and 90 days after treatment)
- Change from baseline in Brief Pain Inventory (BPI-QoL)(at 30, 60 and 90 days after treatment)
研究者
研究点 (4)
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