Osteoarticular Tumor Characterization by Advanced Imaging
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,090
- 试验地点
- 1
- 主要终点
- Contrast enhancement in echography: yes or no
研究概览
简要总结
The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.
Secondary purposes are:
- to determine a possible correlation between some parameters and the histological grade (FNCLCC)
- to suggest a coherent diagnostic imaging approach for osteoarticular tumors.
The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.
详细描述
Patients refered for the initial evaluation of suspected osteoarticular masses will be included in this study after signing an informed consent.
Histologic analysis will be used as a gold standard.
The following imaging techniques will be evaluated:
- contrast enhanced ultrasonography
- Low dose CT perfusion
- Magnetic resonance perfusion
- Diffusion weighted imaging
- Magnetic resonance proton spectroscopy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor
- •patients with normal awareness level
- •patients having signed informed consent
排除标准
- •pregnant women
- •persons deprived of liberty
- •persons under legal protection or unable to give informed consent
- •persons in life-threatening emergency
- •allergy to Sonovue, iodinated contrast media or gadolinium chelates
- •risk of pregnancy
- •breastfeeding women
- •acute coronary syndrome or unstable ischemic cardiopathy (ban on injection of contrast agent for CT scan)
- •renal failure (ban on injection of contrast agent for MRI and CT scan)
- •contraindication to MRI
结局指标
主要结局
Contrast enhancement in echography: yes or no
时间窗: baseline
Gradient of contrast enhancement curve in echography
时间窗: baseline
Vascularization (dynamic analysis) in CT scanner
时间窗: baseline
* 0: absent * 1: low (\< 20UH) * 2: \> 20 UH without new blood vessels * 3: \> 20 UH and/or with new blood vessels
Contrast enhancement curve (absent, slow or fast) in CT scanner
时间窗: baseline
Maximal intensity of enhancement peak in CT scanner
时间窗: baseline
Maximal intensity of enhancement peak in echography
时间窗: baseline
Mean transit time of enhancement in echography
时间窗: baseline
Contrast enhancement curve (absent, slow or fast) in echography
时间窗: baseline
Mean transit time of enhancement in CT scanner
时间窗: baseline
Gradient of contrast enhancement curve in CT scanner
时间窗: baseline
Contrast enhancement curve (absent, slow or fast) in MRI
时间窗: baseline
Maximal intensity of enhancement peak in MRI
时间窗: baseline
Mean transit time of enhancement in MRI
时间窗: baseline
Gradient of contrast enhancement curve in MRI
时间窗: baseline
Choline peak in magnetic resonance spectroscopy
时间窗: baseline
Choline presence was defined as a clear metabolite peak at 3.2 ppm
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging
时间窗: baseline
ADC value in mm2/s
Area under the perfusion curve in MRI
时间窗: baseline
Perfusion curve gradient in MRI
时间窗: baseline
Perfusion time-to-peak in MRI
时间窗: baseline
次要结局
未报告次要终点