Contrast-Enhanced Ultrasound for the Evaluation of Renal Cell Carcinoma Cryoablation
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
研究概览
简要总结
This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current clinical standard, in predicting treatment response in patients with kidney cancer undergoing cryosurgery (a procedure in which an extremely cold liquid or an instrument called a cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced ultrasound that does not involve a dye may help patients avoid side effects from a dye that is usually used in MRI or CT and may help doctors measure blood flow and determine whether the cryosurgery procedure treated the kidney tumor.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate if contrast-enhanced ultrasound can be used to successfully evaluate the cryoablation (cryosurgery) of renal cell carcinoma.
SECONDARY OBJECTIVES:
I. Establish whether contrast-enhanced ultrasound provides a reliable tool for the characterization of renal masses prior to cryoablation.
TERTIARY OBJECTIVES:
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
- •Be scheduled for a percutaneous cryoablation of a renal mass
- •Be medically stable
- •If a female of child-bearing potential, must have a negative pregnancy test
- •Have signed informed consent to participate in the study
排除标准
- •Females who are pregnant or nursing
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:
- •Patients on life support or in a critical care unit
- •Patients with unstable occlusive disease (eg, crescendo angina)
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
- •Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
- •Patients with recent cerebral hemorrhage
- •Patients with known sensitivities to albumin, blood, or blood products
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- •Patients with known hypersensitivity to perflutren
- •Patients who have received any contrast medium (X-ray, MRI, CT, or ultrasound [US]) in the 24 hours prior to the research US exam
- •Patients with cardiac shunts
- •Patients with congenital heart defects
- •Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
- •Patients with respiratory distress syndrome
- •Patients with renal insufficiency such that they can not get intravenous contrast as part of screening or follow-up
研究组 & 干预措施
Diagnostic (contrast-enhanced ultrasound)
Patients receive perflutren protein-type A microspheres IV and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during Magnetic Resonance Imaging (MRI) or computed tomography (CT) follow up.
干预措施: Perflutren Protein-Type A Microspheres (Drug)
Diagnostic (contrast-enhanced ultrasound)
Patients receive perflutren protein-type A microspheres IV and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during Magnetic Resonance Imaging (MRI) or computed tomography (CT) follow up.
干预措施: Dynamic Contrast-Enhanced Ultrasound Imaging (Procedure)
结局指标
主要结局
Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
时间窗: Up to 3-4 months after cryosurgery
Positive predictive value will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.
Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
时间窗: Up to 3-4 months after cryosurgery
Sensitivity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.
Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
时间窗: Up to 3-4 months after cryosurgery
Accuracy will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.
Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
时间窗: Up to 3-4 months after cryosurgery
Negative predictive value will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.
Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
时间窗: Up to 3-4 months after cryosurgery
Specificity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.
次要结局
- Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma(Up to 3-4 months after cryosurgery)
- Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma(Up to 3-4 months after cryosurgery)
- Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma(Up to 3-4 months after cryosurgery)
- Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma(Up to 3-4 months after cryosurgery)
- Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma(Up to 3-4 months after cryosurgery)