Comparison of Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) With Skeletal X-Ray and MRI of the Spine for the Assessment of Bone Disease in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- 1) To assess whether DW-MRI can detect a higher number of bone lesions than standard X-Ray and MRI of the spine
研究概览
简要总结
Bone disease in multiple myeloma (MM) is routinely assessed by skeletal X-ray (XR) and magnetic resonance of the spine (S-MRI). Diffusion-weighted MRI (DW-MRI) is a functional MRI that detects water diffusion through cells. This prospective phase II study compared whole-body DW-MRI with XR and S-MRI for the assessment of MM bone lesions.
METHODS. Thirty-six consecutive symptomatic patients at diagnosis or at relapse performed XR, S-MRI, whole-body MRI, and whole-body DW-MRI before treatment, after treatment, and 6 months after treatment. A substudy evaluated 12 asymptomatic patients at diagnosis, after 6 and 12 months. Radiology exams were independently read by 3 experienced radiologists, and the techniques were compared by the count of segments with focal lesions (FL) (>=5mm).
详细描述
PROTOCOL SYNOPSIS -
Study Type Monocentric prospective clinical trial Study Object Comparison of Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) with skeletal X-Ray and MRI of the spine for the assessment of bone disease in Multiple Myeloma (MM) Objectives
Primary objective 1) To assess whether DW-MRI can detect a higher number of bone lesions than standard X-Ray and MRI of the spine in Stage I-III symptomatic MM patients Secondary objectives
- To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with disease response to therapy
- To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with time to re-treatment (TTR)
- To assess whether DW-MRI detects a higher number of bone lesions than Whole Body Magnetic Resonance Imaging (WB-MRI) Exploratory objective
- To assess whether DW-MRI detects more bone lesions than standard X-Ray and MRI of the spine in Stage I asymptomatic MM patients at diagnosis not requiring treatment Study population and design The study population consists consecutive Stage I-III (Durie and Salmon) symptomatic Multiple Myeloma at the start of the first-line treatment or at relapse after disease response (CR or PR) lasting at least 6 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.Age ≥18 years , < 80 years
- •Stage I-III (Durie-Salmon) symptomatic MM at the start of first-line treatment or at relapse after disease response (CR or PR) lasting at least 6 months
- •Stage I (Durie-Salmon) asymptomatic MM at diagnosis not requiring treatment (substudy for assessment of exploratory objectives)
- •Written informed consent
排除标准
- •Pregnancy or lactation
- •Active secondary malignancy
- •Type I hypersensitivity or anaphylactic reactions to Gadolinum contrast agent
- •Mental disorders including claustrophobia (ICD 10, F40.2)
- •Electronically, magnetically and mechanically activated implants
- •Ferromagnetic or electrically operated active devices like automatic cardioverter defibrillators
- •Cardiac pacemakers
- •Metallic splinters in the eye
- •Ferromagnetic haemostatic clips in the central nervous system (CNS) or in the body
- •Cochlear implants or stapedial implants
- •Insulin pumps and nerve stimulators
- •Prosthetic hearth valves
结局指标
主要结局
1) To assess whether DW-MRI can detect a higher number of bone lesions than standard X-Ray and MRI of the spine
时间窗: 12 months
次要结局
- 3) To assess whether DW-MRI detects a higher number of bone lesions than Whole Body Magnetic Resonance Imaging (WB-MRI)(12 months)
- 1) To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with disease response to therapy(12 months)
- 2) To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with time to re-treatment (TTR)(12 months)
研究者
Paolo Corradini
Professor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano