Clinical Pilot Study of Quantitative MRI Assessment of Bone Marrow in Patients With Acute Lymphoblastic Leukemia and Patients Without Hematopoietic Disorders, From 6 to 18 Years Old
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Dynamics of Bone marrow fat fraction
研究概览
简要总结
The study is aimed at assessing changes in the bone marrow of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy. Patients of the same age without hematological diseases will be recruited as a control group.
详细描述
The ratio of fat to water in the bone marrow depends on the cellularity of the bone marrow. In addition to the water/fat ratio in bone marrow there are also other parameters for quantitative MRI assessment. These include the apparent diffusion coefficient (ACD), the T1 relaxation time, mapping of the macromolecular proton fraction. The undoubted advantage of MRI is its non-invasiveness and the ability to assess any localization of the bone marrow.
MRI may become a new non-invasive method for assessing the ratio of fat to cells in the bone marrow in children with hematological malignancies, which can help in making a diagnosis and monitoring the response to therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients from 6 to 18 years old
- •diagnosis of acute lymphoblastic leukemia during chemotherapy
- •patients of the same age without hematological diseases
排除标准
- •patients less then 6, and older then 18 years old
- •patients who cannot perform the study MRI without general anesthesia
结局指标
主要结局
Dynamics of Bone marrow fat fraction
时间窗: Point 4. through study completion, an average of 2 year
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Dynamics of Bone marrow fat fraction
时间窗: Point 1. Before the start of therapy - the starting point.
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Dynamics of Bone marrow fat fraction
时间窗: Point 2. 15 ± 3 days after the start of the therapy.
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
Dynamics of Bone marrow fat fraction
时间窗: Point 3. 36 ± 3 days after the start of the therapy.
Dynamics of Bone marrow fat fraction by mDixon-quant (%)
次要结局
- T1 maping (ms)(Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year)
- apparent diffusion coefficient (mm2/s)(Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year)
- bone marrow fat fraction (FF) by spectroscopy (%)(Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year)
- The macromolecular proton fraction (MPF)(Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year)