Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Response Assessment in Neuro-Oncology (RANO) to validate biomarkers
研究概览
简要总结
A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.
详细描述
Advances in medical imaging can provide useful information to guide and look at the response to treatment. Previous studies suggest early changes in the tumor after radiation treatment may be detectable using special MRI (Magnetic Resonance Imaging), and CT (Computed Tomography) scans. A biomarker is a measureable indicator of the severity or presence of some disease state. Previous studies suggest that the change in several imaging biomarkers can predict who will respond to radiation treatment. In this study, patients will undergo CT and MRI scans prior to and after radiation treatment to measure these biomarkers. The purpose of this study is to validate the predictive abilities of biomarkers in terms of determining how patients will respond to radiation treatment. This is a single-center phase II study, which will be conducted at the Princess Margaret Cancer Center. The study will be enrolling up to a total of 90 patients who will be receiving radiation treatment for brain metastases. Patients will be asked to participate within this study for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
- •At least one index lesion with diameter > 1cm and without imaging evidence of hemorrhage
- •Patients age > 18 years of age
- •Patients planned for RT to brain metastases
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Previous Whole Brain Radiotherapy
- •Previous radiosurgery to the index lesion
- •Individuals unable to undergo contrasted MRI for whatever reason
研究组 & 干预措施
CT and MRI Scans
Each patient will undergo a 3T MRI scan as well as a dynamic contrast-enhanced CT scan within one week prior to the start of treatment. Patients will also undergo a research 3T MRI scan and research dynamic contrast-enhanced CT scan at the one week post radiotherapy mark. An MRI scan during their 3 month post-treatment follow up visits will take place as per routine standard of care.
干预措施: CT and MRI Scans (Diagnostic Test)
结局指标
主要结局
Response Assessment in Neuro-Oncology (RANO) to validate biomarkers
时间窗: Up to 2 years.
Using RANO to validate imaging predictive biomarkers of response to radiotherapy
Progression Free Survival (PFS) to validate biomarkers
时间窗: Up to 2 years.
Using PFS to validate imaging predictive biomarkers of response to radiotherapy
Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers
时间窗: Up to 2 years.
Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy
次要结局
- Objective (Radiological) Progression(Up to 2 years.)
- Time to Intracranial Local Progression(Up to 2 years.)
- Objective (Radiological) Response(Up to 2 years.)
- Time to Intracranial Distant Progression(Up to 2 years.)
- Brain Progression Free Survival(Up to 2 years.)
- Unexpected and/or Serious Toxicities (AEs)(Up to 2 years.)