Evaluation of Whole Body Examination by MRI Integrating the "Zero Time Eco" Sequence (ZTE, Pseudo-CT) for the Detection of Bone Lesions in Multiple Myeloma: Comparison With Pet / CT and Whole Body Scanner
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluation of the diagnostic performance of the different imaging protocols
研究概览
简要总结
To assess the added value of magnetic resonance imaging (MRI) of the skeleton compared to other validated techniques for the detection of bone lesions in patients with multiple myeloma.
详细描述
The aim of our study is to offer patients benefiting from a diagnostic approach to myeloma by PET / CT, a whole body MRI examination (MRI-CE) comprising, in addition to the "classic bone marrow" sequences, a ZTE sequence (see below) . This study is being undertaken to compare and assess the complementarity of imaging techniques in the diagnostic management of this disease.
The stages of the work will be:
Optimizing bone marrow exploration sequences by MRI (F. Lecouvet, N. Michoux, Gaetan Duchêne).
Develop and validate a whole body-wide new MRI sequence "ZTE" capable of detecting and quantifying disease-induced osteolysis in the skeleton.
Optimize the reconstruction of these images (Deep Learning software developed with the firm GE), training of the reconstruction of ZTE images by correlation with the scanner (F. Lecouvet, N. Michoux, Gaetan Duchêne).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with newly diagnosed multiple myeloma, for whom bone imaging is required for staging.
- •Recurrent patient after intensive treatment (high dose chemotherapy, bone marrow transplant, etc.).
- •Patient requiring a PET / CT considered as the technique of choice in these stages of the disease.
排除标准
- •Implanted material incompatible with MRI.
- •Severe claustrophobia.
- •Pregnant women
结局指标
主要结局
Evaluation of the diagnostic performance of the different imaging protocols
时间窗: through study completion, an average of 1 year
The diagnostic performance of the different imaging protocols will be evaluated by analyzing the receptor efficiency function (ROC curve) and by estimating the Sensitivity (Se), Specificity (Sp), Positive Predictive Value (PPV), Negative Predictive Value (NPV) ) as well as the Predictive Accuracy (Acc) of the different imaging protocols.
Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols
时间窗: through study completion, an average of 1 year
McNemar test on paired data. The Gold Standard will be determined by a panel of independent experts based on all available imaging techniques.
次要结局
未报告次要终点
研究者
Lecouvet
Prof
Cliniques universitaires Saint-Luc- Université Catholique de Louvain