Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Pattern-of-failure analysis
研究概览
简要总结
The goal of this prospective cohort study is to assess the potential of advanced MRI for improved radiotherapy target delineation in patients diagnosed with glioblastoma. The main questions it aims to answer are:
- How does the coverage of the recurrence volume by a radiotherapy plan based on advanced MRI compare to the coverage by the clinical radiotherapy plan?
- How does the distribution of the dose to organs at risk by a radiotherapy plan based on advanced MRI compare to the distribution by the clinical radiotherapy plan?
Participants will undergo an extended MRI-protocol prior to radiotherapy. This extended MRI-protocol includes the clinical brain tumor imaging protocol plus additional advanced MRI-sequences. Radiation treatment and patient follow-up will occur according to the clinical standard.
详细描述
Rationale: One of the fundamentals of glioblastoma management is radiotherapy, where ionizing radiation is aimed towards a specific target area in the brain to inhibit further tumor growth. As these brain tumors are notorious for their extensive tumor infiltration, where tumor grows beyond the tumor that is visible on conventional magnetic resonance imaging (MRI), this target area, defined as the clinical target volume (CTV), consists of the visible tumor plus a 1.5-cm isotropic safety margin. In the majority of cases, this unspecific CTV margin adequately covers tumor infiltration, but inevitably also includes considerable amounts of healthy tissue. Radiation-induced side-effects like headaches, nausea, fatigue and cognitive decline can substantially affect the quality of life for these patients. An opportunity arises to indirectly visualize tumor infiltration with state-of-the-art advanced MRI (aMRI) techniques, providing additional information on biology rather than only showing anatomical information through conventional MRI. A workflow has been developed to create a CTV based on these aMRI scans (CTVbio) rather than an isotropic expansion. With the additional information that aMRI provides, it could be possible to more accurately define what needs to be targeted and thus minimize damage to healthy tissue. In this research, the aim is to assess the potential of integrating aMRI into radiotherapy target delineation for patients with a glioblastoma by comparing the pattern of failure (coverage of first tumor recurrence by the radiotherapy plan) and the expected radiation dose to organs at risk between the CTVbio and the 1.5-cm CTV. It is hypothesized that the CTVbio can result in decreased radiation dose to organs at risk, whilst having similar pattern of failure.
Primary objective:
• To demonstrate that the probability for reduced coverage of the recurrence volume by a radiotherapy plan based on a CTVbio, compared to the clinical radiotherapy plan (1.5-cm CTV), is lower than 0.20.
Secondary objectives:
- To illustrate a reduction in dose to organs at risk with a radiotherapy plan based on a conceptual CTVbio compared to the clinical radiotherapy plan (1.5-cm CTV).
- To evaluate the synergistic information that each individual aMRI-scan provides for the identification of tumor infiltration.
- To explore the association between pathophysiological changes on aMRI and future tumor recurrence.
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
- •Written informed consent;
- •Adult (18 years or older);
- •Diagnosed with IDH-wildtype glioblastoma, as confirmed by pathology including molecular analysis post resection/biopsy;
- •Referred to the outpatient clinic of the Dept. of Radiotherapy to undergo standard treatment with radiotherapy (30x2 Gy or 15x2.67Gy or 10x3.4Gy).
排除标准
- •Contraindication for (3 Tesla) MRI;
- •Contraindication for use of gadolinium-based contrast agent (e.g. subject having renal deficiency or known allergy);
- •Referred for treatment of recurrent glioblastoma;
- •Previous radiotherapy to the brain;
- •Unable to give informed consent
结局指标
主要结局
Pattern-of-failure analysis
时间窗: The time frame is until tumor recurrence occurs (follow-up for this study will last 2 years maximum for a participant).
The primary outcome measure is a comparison of the pattern-of-failure by the radiotherapy plan based on CTVbio and the clinical radiotherapy plan (1.5-cm CTV). For both the clinical radiotherapy plan and the aMRI radiotherapy plan of each patient, the recurrence volumes will be classified as in-field, marginal, or distant recurrence if more than 80%, 20-80%, or less than 20% of the recurrence volume falls within the 95% isodose line, respectively.
次要结局
- Distribution of dose to organs at risk.(Through study completion (on average 1 year after the extended MRI-scan).)
- Recurrence coverage by different combinations of CTVbio(The time frame is until tumor recurrence occurs (follow-up for this study will last 2 years maximum for a participant).)
- Signal intensity on aMRI at the site of tumor recurrence(The time frame is until tumor recurrence occurs (follow-up for this study will last 2 years maximum for a participant).)
研究者
Alejandra Mendez Romero
Radiation oncologist and Associate professor - Department of Radiotherapy
Erasmus Medical Center