Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Intercept
研究概览
简要总结
The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with suspected kidney cancer with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)
详细描述
This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Eligible patients will include anyone who has suspected kidney cancer and is scheduled for surgery, up to an anticipated total of 40 participants. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.
Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.
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
- •A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
- •Able to provide informed consent
- •Willing to comply with protocol requirements
- •At least 18 years of age
排除标准
- •Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable
- •Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
- •Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
- •Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives
- •Unstable cardiopulmonary disease including any of the following:
- •Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
- •Unstable angina
- •Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
- •Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
- •Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
- •Obesity that limits obtainment of acceptable images
研究组 & 干预措施
Perflutren Lipid Microsphere or Lumason
Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
干预措施: Perflutren lipid microsphere (Drug)
Perflutren Lipid Microsphere or Lumason
Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
干预措施: Sulfur hexafluoride lipid microspheres (Drug)
结局指标
主要结局
3D CEUS Generated Metric in Kidney Mass: Wash_Out_Intercept
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash_Out_Intercept parameter was generated. This metric indicates the intensity level of contrast at a steady state of enhancement in the mass. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. This value was calculated using an equation for a line that has a slope and an intercept.
3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash_In_Slope parameter was generated. This metric indicates the change in contrast with time in the mass using bolus imaging. Bolus imaging injects a small amount of contrast agent and monitors the contrast agent as it flows in (wash-in) and out (wash-out) of the body/mass. The intensity of the signal (the brightness of the image) is plotted over time to generate the time-intensity curve. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White.The Wash_In_Slope increases as the contrast agent is introduced to the body/mass. This value was generated by fitting the data to a linear equation. Increasing brightness is related to the slope of curve.
3D CEUS Generated Metric in Kidney Mass: Wash_In_intercept
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash_In_intercept parameter was generated. This metric indicates the intensity level prior to infusion of contrast. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=white. This value was calculated using an equation for a line which has a slope and the intercept. The values were negative because they were calculated (not measured).
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_intercept
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash_In_intercept parameter was studied. This metric indicates the intensity level prior to infusion of contrast. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=White. This value was calculated using an equation for a line which has a slope and the intercept. The values were negative because they were calculated (not measured).
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Intercept
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash_Out_Intercept parameter was studied. This metric indicates the intensity level of contrast at steady state of enhancement in the mass. The contrast-enhanced ultrasonogram (CEUS) Wash_Out_Intercept parameter was generated. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=White. This value was calculated using an equation for a line which has a slope and the intercept.
3D CEUS Generated Metric in Kidney Mass: Wash_Out_Slope
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash_Out_Slope parameter was generated. This metric indicates the change in contrast with time in the mass using bolus imaging. Bolus imaging injects a small amount of contrast agent and monitors the contrast agent as it flows in (wash-in) and out (wash-out) of the body/mass. The intensity of the signal (the brightness of the image) is plotted over time to generate the time-intensity curve. The intensity of the signal (the brightness of the image) value range was between 0=black and 255=White. The wash Out slope decreases as the contrast agent clears the body/mass. Decreasing brightness is related to the slope of the curve. This results in a negative number. This value was generated by fitting the data to a linear equation.
3D CEUS Generated Metric in Kidney Mass: FR_a
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) FR_a parameter was generated. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=white. The intensity was plotted by time. FR_a parameters were devised from an exponential fit. The exponential fit of the data provides the height of the curve.
3D CEUS Generated Metric in Kidney Mass: FR_beta
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) FR_beta parameter was generated. The intensity of the signal (the brightness of the image) value range is between 0=black, 255=White. The intensity was plotted by time. FR_beta parameters were devised from an exponential fit. Exponential fit of the data provides the slope of the curve.
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_Slope
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash_In_Slope parameter was studied. This metric indicates the change in contrast intensity with time in the mass using bolus imaging. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. The Wash_In_Slope increases as the contrast agent is introduced to the body/mass. This value was generated by fitting the data to a linear equation. Increasing brightness is related to the slope of the curve.
3D CEUS Generated Metric in Kidney Mass: Volume
时间窗: Baseline- up to 3 minutes
A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) volume parameter was generated. The volumes were generated using the ellipsoid equation on the CEUS image of the kidney mass.
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_beta
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated FR_ beta parameter was studied. The contrast-enhanced ultrasonogram (CEUS) FR_beta parameter was generated. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. The intensity was plotted by time. FR_beta parameters were devised from an exponential fit. The exponential fit of the data provides the slope of the curve.
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Slope
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash_Out_Slope parameter was studied. This metric indicates the change in contrast intensity with time in the mass using bolus imaging. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=White. Decreasing brightness is related to the slope of the curve. The Wash Out slope decreases as the contrast agent clears the body/mass. Decreasing brightness is related to the slope of the curve. This results in a negative number. This value was generated by fitting the data to a linear equation.
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_a
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated FR_a parameter was studied. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. The intensity was plotted by time. FR_a parameters were devised from an exponential fit. The exponential fit of the data provides the height of the curve.
3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Volume
时间窗: Baseline- up to 3 minutes
The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated volume parameter was studied. The volumes were generated using the ellipsoid equation on the CEUS image of the kidney mass.
次要结局
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_Slope(Baseline- up to 3 minutes)
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Volume(Baseline- up to 3 minutes)
- Pooled Kidney Mass Stage vs. 3D CEUS-generated Wash in Metrics(Baseline- up to 3 minutes)
- Pooled Kidney Mass Stage Using 3D CEUS-generated Wash Out Metrics(Baseline- up to 3 minutes)
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_intercept(Baseline- up to 3 minutes)
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Slope(Baseline- up to 3 minutes)
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Intercept(Baseline- up to 3 minutes)
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_a(Baseline- up to 3 minutes)
- 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_beta(Baseline- up to 3 minutes)