A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- The time-to-progression as measured by Saturation Transfer (ST)-MRI (based on a change in volume or parameter value of over 10%) relative to the time-to-progression as measured by standard MRI using RANO-LGG.
研究概览
简要总结
Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that typically present in the younger population. This project proposes to use non-contrast metabolic "Saturation Transfer" (ST)-MRI to evaluate LGG tumour progression and aims to predict early changes in LGG. Early identification of LGG patients whose tumours will progress will permit early interventions. ST-MRI does not involve any intravenous injection of contrast and which acquires metabolic information not seen by standard MRI.
详细描述
Please see trial details below:
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 12 years of age;
- •Diagnosed with:
- •Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based on any combination of histological, molecular, radiological, and/or clinical findings; or
- •Cohort B (post-surgical): IDH1/2-mutant or IDH-wildtype (WT) low-grade glioma candidate for observation
- •No contraindications to MRI;
- •eGFR > 30 ml/min;
- •No prior chemotherapy or radiation therapy;
- •No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy)
- •Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital
排除标准
- •Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
结局指标
主要结局
The time-to-progression as measured by Saturation Transfer (ST)-MRI (based on a change in volume or parameter value of over 10%) relative to the time-to-progression as measured by standard MRI using RANO-LGG.
时间窗: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression
Time-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade.
次要结局
- Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%).(Up to 6 years, from date of initial (ST)-MRI scan until the date of progression)
研究者
Dr. MaryJane Lim Fat
Principal Investigator
Sunnybrook Health Sciences Centre