Does Contrast-Enhanced Ultrasound Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Abnormal Biopsy
研究概览
简要总结
This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus help direct the biopsy to the most abnormal part of the renal cortex. This should maximize detection and increase the odds of demonstrating the true grade/severity of the histopathological abnormality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
For Cause
For cause biopsies to evaluate a recent rise in serum creatinine.
干预措施: Optison (Drug)
For Cause
For cause biopsies to evaluate a recent rise in serum creatinine.
干预措施: Ultrasound (US) (Diagnostic Test)
For Cause
For cause biopsies to evaluate a recent rise in serum creatinine.
干预措施: Contrast-enhanced ultrasound (CEUS) (Diagnostic Test)
Surveillance
Surveillance biopsies done after transplant mostly looking for subclinical rejection.
干预措施: Optison (Drug)
Surveillance
Surveillance biopsies done after transplant mostly looking for subclinical rejection.
干预措施: Ultrasound (US) (Diagnostic Test)
Surveillance
Surveillance biopsies done after transplant mostly looking for subclinical rejection.
干预措施: Contrast-enhanced ultrasound (CEUS) (Diagnostic Test)
结局指标
主要结局
Abnormal Biopsy
时间窗: 1 year
Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist
次要结局
- Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.(1 year)
研究者
J. Scott Kriegshauser, M.D.
Principal Investigator
Mayo Clinic