Quantitative Ultrasound Spectroscopy to Early HCC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Spectral slope
研究概览
简要总结
This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVES:
I. To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.
OUTLINE:
Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.
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
- 是
入选标准
- •For Healthy Volunteers
- •Patients over 18 years of age.
- •Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures.
- •For HCC patients
- •Patients over 18 years of age.
- •Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC (Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or Patients at a higher risk of HCC undergoing a screening program by Ultrasound.
排除标准
- •For Healthy volunteers
- •Patients who are not likely to comply with the protocol requirements.
- •For HCC patients
- •Patients should not be taking other Investigational Agents.
- •Concomitant medications for treatment of the target lesion.
结局指标
主要结局
Spectral slope
时间窗: Up to 16 months
Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole.
Mid-band fit
时间窗: Up to 16 months
The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology.
Spectral intercept
时间窗: Up to 16 months
Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged.
次要结局
未报告次要终点
研究者
Aya Kamaya
Professor of Radiology
Stanford University