Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging (MRTI) and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Feasibility: Rate of technical success or failure to complete initial procedure with no associated major complications.
研究概览
简要总结
The goal of this clinical research study is to learn about a new therapy device called the Visualase® Thermal Therapy System (a device that uses a laser to kill tumor cells and is guided using magnetic resonance thermal imaging [MRTI]). The Visualase® Thermal Therapy System is used to treat metastatic brain tumors. Researchers want to find out if it is possible to use this new device in patients with metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.
详细描述
The Study Device and Process:
The Visualase® Thermal Therapy System combines 3 FDA-approved devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) beams to the tumor tissue; the PhoTex 15 Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.
The Visualase® Thermal Therapy System will be used in this study to give patients a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.
LITT is less invasive than an open surgical procedure. There are no radiation-related side effects, or limits on the number of times it can be repeated. Also, since the procedure is performed using the MRTI, doctors can find out right away how effective the therapy was by using special imaging sequences, which may also show any surviving tumor cells.
Screening:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or family able and willing to give informed consent.
- •Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy). Failure is defined as local recurrence or failure of the previously treated lesion and will be determined by the treating surgeon based on a review of patient history and imaging.
- •Tumor size </= 3.0 cm in largest diameter.
- •MR imaging is not contraindicated for the patient
- •Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
- •Able and willing to attend all study visits.
- •Karnofsky Performance Scale score >/=70 for patients over the age of
- •Lansky Play Scale>/=70 for patients 15 years of age or younger.
排除标准
- •Patients or family unwilling or unable to give written consent.
- •Patients who cannot physically fit in, or are too heavy for, the BrainSUITE® MRI scanner
- •Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects
- •Known sensitivity to gadolinium-DTPA
- •Based on Treatment Planning Imaging (MR and/or CT) done on the day of treatment: -Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm. -Lesions localized in the brain stem or the posterior fossa. -Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves. -Evidence of recent (<2 weeks) hemorrhage.
- •Symptoms and signs of increased intracranial pressure
- •Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
- •Patients who are unable to received corticosteroids.
- •Positive pregnancy test for women of child-bearing age.
结局指标
主要结局
Feasibility: Rate of technical success or failure to complete initial procedure with no associated major complications.
时间窗: Safety: 30, 90, 180 day procedure-related morbidity and mortality
次要结局
未报告次要终点