Imaging After Stereotactic Radiosurgery for Brain Metastases or Primary Tumor Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease ?
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Distinguish between progressive tumor and treatment related effects
研究概览
简要总结
PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details will be performed on set intervals to patients with brain tumor & brain metastases in order to try to optimize the study protocol, distinguish between pseudo-response to anti-angiogenic therapy and tumor progression, and most importantly try to distinguish between progressive tumor and treatment related effects.3 cohort of patients will be included in the study.
详细描述
The multimodality approach for management of primary and secondary brain tumors includes surgery, radiotherapy and chemotherapy. Determination of an objective response to treatment relies on imaging findings (e.g. CT, MRI, PET).During the course of the disease patients with brain tumors often develop new or worsening contrast-enhancing lesions on routine follow-up imaging.These lesions may reflect tumor recurrence, treatment effect, or a combination of both. Discerning between tumor recurrence and treatment effect is clinically significant issue and a major challenge in neuro-oncology. Treatment-related effects exist within a spectrum, with "pseudoprogression" reflecting subacute and often transient injury, and "radiation necrosis" reflecting later and more permanent damage.The difficulty in differentiating tumor progression from treatment-related effects has serious implications for individual patient treatment decisions and prognosis as well as for clinical trial design and interpretation of results.
A contemporary hybrid scanner technology is capable of acquiring both metabolic information from PET and morphological and functional details from MRI. This new integrated technique opens new horizons for clinical and research evaluation of brain tumors and the associated treatment effects.
The aim of the current study is to use the combined data obtained by PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details in order to:
- Distinguish between progressive tumor and treatment related effects
- To identify pseudo-response to antiangiogenic therapy from tumor progression
- To optimize the study protocol of PET-MRI for future routine clinical application.
The study will include three cohorts of patients with brain tumors:
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with glial brain tumors,
- •Subjects with metastatic brain tumors that were treated with stereotactic radiation (SRS), * Subjects with metastatic brain tumors which were not treated
排除标准
- •glial tumor with no histological diagnosis
- •non breast of lung metastasis
- •non compliance
- •unable to lay still during the scanning
- •renal failure/gadolinium sensitivity
- •less than 5 mm metastatic tumors
- •bleeding brain tumors
- •pregnancy
结局指标
主要结局
Distinguish between progressive tumor and treatment related effects
时间窗: 1st scan: after surgery or biopsy and before any further treatment - 2nd scan: up to 4 weeks after completing the combined radiotherapy and chemotherapy regimen. - 3rd and 4th scans - 3 month interval apart
finding PET-MRI difference between progression and treatment effect correlating with clinical out come
次要结局
未报告次要终点
研究者
Michal Guindy
Medical Director of Imaging Services
Assuta Medical Center