A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 101
- 主要终点
- Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
研究概览
简要总结
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.
详细描述
Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
- •Willing and able to provide informed consent and to participate in all evaluations.
排除标准
- •Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
- •Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
- •Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.
研究组 & 干预措施
GammaTile
Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
干预措施: GammaTile (Device)
结局指标
主要结局
Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
时间窗: 3 years
No contrast enhancement in the area of the surgical bed
Overall Survival in High Grade Glioma Subjects
时间窗: 9 months
Median duration of survival of subjects following surgical resection of tumor
Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
时间窗: 12 months
No contrast enhancement in the area of the surgical bed
次要结局
未报告次要终点