A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients
研究概览
简要总结
Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. A special immobilization device can be used to keep the head from moving.
This device does not need any pins and does not hurt. We would like to see if the new way of holding the head still can be used for SRS. This is the purpose of the study. New X-Ray machines can be used to find if the head has moved in the mask. We hope that we can use these new tools to treat brain tumors just as accurately without using a head frame. It will make treatment more comfortable for the patient. This is why we are asking patients to join the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.
- •A diagnostic contrast enhanced MRI demonstrating the presence of brain metastases performed within two weeks prior to registration.
- •Age ≥ 18 years.
- •Must be scheduled or planning to be scheduled for SRS treatment.
- •Karnofsky performance status ≥
- •Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
排除标准
- •Unable to provide informed consent
- •Major medical illness including poor cardiac or pulmonary status which would result in inability of the patient to lie down for the procedure.
- •Inability to obtain histologic proof of malignancy.
- •Younger than 18 years of age.
- •Serum creatinine > 1.3 mg/dl.
- •Karnofsky performance status of ≤
- •Allergy to either CT or MR contrast dyes.
结局指标
主要结局
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients
时间窗: conclusion of study
次要结局
- Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the accuracy of an image guided non-invasive (Aktina stereotactic localizer) immobilization system on the same 10 patients as in above.(conclusion of study)
- Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.(conclusion of the study)
- Compare setup accuracy of both systems above, and investigate the feasibility of 'system B' as replacement for 'system A' for single fraction SRS(conclusion of the study)