Percutaneous Renal Tumor Cryoablation Followed by Biopsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To determine the efficacy rate after percutaneous renal cryoablation.
研究概览
简要总结
This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one renal cancer smaller than or equal to 3.0 cm
- •Adequate baseline imaging studies (CT/MRI) within 8 weeks of treatment or as clinically indicated.
- •The following laboratory results should be within the following limits within the last 30 days prior to study day
- •Repeat blood work will be necessary if too much time has elapsed prior to the interventions.:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •Serum bilirubin ≤ 2.0 mg/dL
- •Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
- •Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- •Serum creatinine ≤ 2.0 mg/dL
- •GFR >30 mL/min/m2
- •International Normalized Ratio < 1.5 (INR)
- •Partial Thromboplastin Time (PTT) <45 seconds
- •Recovered from toxicity of any prior therapy
- •Tumor accessible to probe placement without risk to adjacent critical structures.
- •Tumor visible on non-contrast CT
- •Patient willing and able to undergo imaging and percutaneous biopsy at 5-7 month intervals for 2 years and then at the discretion of the patient's physicians.
排除标准
- •Intercurrent medical condition that renders the patient ineligible for cryoablation
- •Women who are pregnant or breastfeeding.
- •Tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure
- •Contraindication to MRI in patients in which it is required.
- •Coagulopathy as defined above (Inclusion Criteria).
- •Patients unwilling to return for follow-up biopsy and imaging.
结局指标
主要结局
To determine the efficacy rate after percutaneous renal cryoablation.
时间窗: 2 years
次要结局
- To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.(2 years)
- To determine the complication rate of percutaneous renal tumor cryoablation.(2 years)
- To investigate predictors of efficacy after cryoablation.(2 years)
- To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.(2 years)