NCT03616860已完成不适用
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Device and procedure related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard chemo-radiation with temozolomide (TMZ) protocol and ready for the maintenance phase of the Stupp protocol with TMZ.
详细描述
This is a prospective, single center, single-arm study to establish the safety, feasibility, and effectiveness of BBB disruption along the periphery of the tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system and DEFINITY ultrasound contrast in patients with GBM. Adult patients with a first time diagnosis of GBM, whom have undergone maximal safe surgical resection and have safely completed the initial phase of concurrent chemo-radiation therapy, will be recruited for this study. Twenty patients will undergo up to 6 treatments with FUS coincident with their standard TMZ cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women.
- •Age between 18 and 80 years, inclusive.
- •Able and willing to give informed consent.
- •Grade IV malignant glioma (GBM) confirmed through assessment of surgical specimens by a board-certified neuropathologist.
- •Undergone maximal safe surgical resection and completed concurrent radiotherapy+oral TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.
- •Karnofsky rating 70-
- •ASA score 1-
- •Able to communicate during the ExAblate MRgFUS procedure.
- •Able to attend all study visits (i.e., life expectancy of at least 3 months).
排除标准
- •Patients presenting with the following imaging characteristics:
- •i. Evidence of recent intracranial hemorrhage.
- •The sonication pathway to the tumour involves:
- •i. Extensive scalp scars, ii. Clips or other metallic implanted objects in the skull or the brain (brain implants).
- •The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- •Patients requiring increasing doses of corticosteroids.
- •Patient receiving bevacizumab (Avastin) therapy.
- •Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy.
- •Cardiac disease or unstable hemodynamics including:
- •i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction <50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.
- •Severe hypertension (diastolic BP > 100 on medication).
- •Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment.
- •History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage.
- •Documented cerebral infarction within the past 12 months.
- •TIA in the last 1 month.
- •Cerebral or systemic vasculopathy.
- •Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.
- •Known sensitivity to gadolinium-DTPA.
- •Known sensitivity to DEFINITY ultrasound contrast agent or perflutren.
- •Contraindications to MRI such as non-MRI-compatible implanted devices.
- •Large subjects not fitting comfortably into the MRI scanner.
- •Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia.
- •Untreated, uncontrolled sleep apnea.
- •Positive pregnancy test (for pre-menopausal women).
- •Known life-threatening systemic disease.
- •Severely impaired renal function.
- •Cardiac shunt.
- •Previous full course of chemotherapy.
- •Allergy to eggs or egg products.
- •Subjects with evidence of cranial or systemic infection.
- •Subjects with chronic pulmonary disorders.
- •Subjects with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular subjects with a history of anaphylaxis.
- •Subjects with evidence of Hepatitis B virus infection/carrier state.
- •Liver injury as indicated by liver function tests.
结局指标
主要结局
Device and procedure related adverse events
时间窗: Throughout the study, approximately 12 months.
The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE
次要结局
- Effectiveness of BBB disruption in the treated tumor region(at each standard of care neuro-oncology follow up visit until date of death from any cause, assessed up to 48 months)
- Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging(Immediately after each FUS BBB disruption procedure)
研究者
研究点 (2)
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