Clinical Study of the Sensitivity and Specificity of the Quantitative Assessment of Bone Marrow Cellularity by MRI in Comparison With Trepanobiopsies in Patients With Diseases of the Hematopoietic System
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.
研究概览
简要总结
The study is aimed to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters.
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 cellularity of the bone marrow in children with oncohematological diseases.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of indications for performing trepanobiopsy:
- •aplastic anemia
- •chronic myeloproliferative disease
- •reactive changes in hematopoiesis
排除标准
- •Refusal to sign an informed consent to participate in a clinical trial
- •Presence of contraindications for MRI examination
- •Extremely serious condition of the patient at the time of inclusion in the study.
结局指标
主要结局
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.
时间窗: Before the start of treatment
Determination of bone marrow cellularity before starting therapy for the underlying disease. Cellularity according to trepanobiopsy data is the ratio of stromal and hematopoietic cells to fat cells in the bone marrow. Cellularity according to MRI - the ratio of water and fat in the bone marrow using the mDixom Quant.
次要结局
- apparent diffusion coefficient(Before the start of treatment)
- Percentage of the macromolecular proton fraction (MPF)(Before the start of treatment)
- Percentage of the bone marrow fat fraction(Before the start of treatment)
- T1 maping(Before the start of treatment)