Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Time to Recurrence of Brain Tumor (anywhere in brain)
研究概览
简要总结
The goals of this study are to evaluate each of the following items:
- Time to recurrence in patients receiving brachytherapy with the GliaSite RTS
- Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy System (RTS).
- Incidence of serious adverse events in patients treated with GliaSite RTS
详细描述
Your doctor has found that you have a brain tumor that needs to be surgically removed. Your doctor has explained the risks and benefits of the surgery. After the brain tumor is surgically removed, some tumor may be left. A treatment that sends additional radiation right to the place around where the tumor was located, may help kill any tumor cells left after the surgery. This treatment is called brachytherapy. Your doctor has explained the risks and benefits of brachytherapy. Researchers in this study would like to evaluate a radiation delivery system, GliaSite RTS, that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
The GliaSite RTS is a balloon attached to the end of a tube with an access port. The balloon will be put in the space left behind after your tumor is taken out. The end of the tube with its access port will be on the outside of your skull, underneath the skin, at the top of your head. The balloon is filled with radiation therapy solution to provide radiation therapy to any remaining tumor cells next to the space where the tumor was removed.
Before your already scheduled surgery, a series of tests will be performed to find out if you qualify for participation in this study. You will have a complete medical history and your temperature, blood pressure, and pulse will be measured. A standard neurological exam will be performed, in which your mental status, vision, sensory functions, speech, motor skills, and functioning will be evaluated. Women who are able to have children must have a negative urine or blood pregnancy test. A MRI/CT scan will be taken of your head. As part of this MRI/CT, you will get an injection of a contrast solution into your vein. The MRI/CT images will show if there is brain swelling or bleeding. It will also show the edges of the tumor area and will be used to confirm that you should receive radiation therapy with the GliaSite RTS.
If you qualify for the study, you will have a small balloon (GliaSite) placed in the space where the tumor was removed during your surgery. The balloon will be filled with an x-ray dye and normal saline (sterile water with salt) to make sure that the balloon properly fills the space where the tumor was removed. Your surgeon will then stitch your head closed. It is possible that your surgeon may decide not to place the GliaSite device in the space where the tumor was. If your surgeon chooses not to place the GliaSite device, you will be offered alternative treatments, once you recover from surgery.
The balloon will be filled with an x-ray dye solution once it has been placed in the surgical cavity and will be kept filled until it is replaced by the radioactive solution. You will then have an MRI/CT of the head. Following this MRI/CT exam, you will get an injection of a contrast solution into your vein. You will then have a second MRI/CT exam of the head, which will show this contrast solution. The MRI/CT images will show if there is brain swelling or bleeding. It will also show the edges of the tumor area and where the balloon is located. These images will be used to confirm that you should receive radiation therapy with the GliaSite RTS device. You may also have x-ray films of the brain to confirm balloon placement. You may be able to leave the hospital after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have histologically proven malignant brain tumor
- •Patient must be a candidate for surgical resection of the tumor mass.
- •Patient must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
- •Patient must sign informed consent form
排除标准
- •Serious concurrent infection or medical illness which could jeopardize the ability of the patient to receive the GliaSite catheter with reasonable safety.
研究组 & 干预措施
GliaSite Radiation Therapy System (RTS)
Surgical removal of brain tumor followed by GliaSite RTS targeted brachytherapy to the specific brain tumor site
干预措施: GliaSite Radiation Therapy System (Device)
结局指标
主要结局
Time to Recurrence of Brain Tumor (anywhere in brain)
时间窗: From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence.
Time to recurrence of brain tumor determined for each patient from the time at the end date of brachytherapy with the GliaSite RTS until the date of documented brain tumor recurrence.
次要结局
- Overall Patient Survival(Time from completion of the GliaSite procedure to death by any cause (time in months).)