A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Glioma
- 发起方
- InSightec
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events
- 状态
- 撤回
- 最后更新
- 去年
概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical resection, for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection (GTR) per plan compared to those not undergoing a BBBD procedure prior to resection (Control Arm).
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a 2:1 ratio to Exablate Test Arm and to Control Arm, respectively. The following assessments will occur: 1. Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab; Any return to surgery for additional resection will be captured 2. All subjects will be seen at \~Week 2, and \~4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events. These visits should coincide with standard (Neuro-oncology) care following resection. 3. Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection; standard of care MRIs and RANO assessments will be collected.
研究者
入排标准
入选标准
- •Male or Female between 21-85 years of age who are able and willing to give informed consent
- •Subjects with suspected Grade II, III or IV infiltrating glioma (IG) on pre-operative brain imaging scans who have a non-enhancing component and are planned for surgical resection.
- •Karnofsky Performance Score 70-100
- •Able to communicate sensations during the Exablate BBBD procedure
排除标准
- •Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
- •Multifocal tumors
- •MRI or clinical findings of:
- •Active or chronic infection(s) or inflammatory processes
- •Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages
- •Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
- •More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- •MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices
- •Significant cardiac disease or unstable hemodynamic status
- •Documented myocardial infarction within six months of enrollment
结局指标
主要结局
Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events
时间窗: Approximately 2 months
Safety of the Exablate BBBD procedure will be evaluated by patient examination and post-procedure MRI exams assessing changes in the treated region. Adverse events will be reported by the Investigator and monitored in both treatment arms.
Effectiveness of BBBD as determined by the proportion of subjects in whom a GTR is acheived
时间窗: MRI 72 hours post resection
The proportion of subjects in whom a gross total resection (actual versus planned) is achieved as measured on post-operative imaging compared to pre-resection imaging
次要结局
- Confirmation of accuracy of Exablate BBBD targeting(MRI immediately after the ExAblate procedure)
- Return Rate for Second Surgery for Completion of Resection(Approximately 2 months)