Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Vertebral fracture severity score
研究概览
简要总结
Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..
详细描述
Patients treated with vertebroplasty will be included during the period of the study, retrospectively or prospectively.
Mains collected data are represented by :
- Bone marrow fat fraction determined by MRI
- Severity score for vertebral fractures
- Clinical prognostic factors
- Biological prognostic factors
- Clinico-biological scores Descriptive statistics and correlation analyses will be performed between the measured parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group
- •vertebral fractures treated by vertebroplasty from January 2017 to December 2021
- •recent clinical and biological data available at the time of imaging and fracture events
排除标准
- •Factors modifying the bone marrow fat fraction (extensive radiotherapy)
- •Lack of recent clinical or biological data compared to imaging examinations
结局指标
主要结局
Vertebral fracture severity score
时间窗: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Score established according to morphological criteria determined by MRI/computerized tomography scan, based on the Genant classification. Calculation of sum of the points awarded as follows: vertebral fracture on osteolytic lesion = 3; osteolytic lesion with high fracture risk = 0; other fracture related to increased bone fragility, scale 1-3 according to Genant's criteria, 3 representing the worst situation; normal vertebra = 0.
Percentage of bone marrow fat in vertebral bone marrow
时间窗: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Measured from Dixon sequences on MRI exams performed in routine care, for the assessment of the relationship between bone marrow vertebral fat content and the severity of the vertebral fractures
次要结局
- Salmon-Durie Plus classification(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Weight/body mass index (BMI)(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Sex(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Age at the diagnosis of multiple myeloma(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Serum rate of the monoclonal component(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Presence of hypercalcemia(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Presence of amyloidosis(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Multiple myeloma stage according to the International Staging System (ISS)(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Type of bone damage on CT scan(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Age at the moment of the vertebral fracture(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Presence of anaemia(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Type of the monoclonal component(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Medullary plasmacytosis(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Presence of renal failure related to myeloma(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Multiple myeloma stage according to the Salmon-Durie staging System(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Serum rate of Lactate dehydrogenase(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)
- Vertebral radiodensity(At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty)