VisR Ultrasound for Noninvasively Monitoring Renal Allograft Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- VisR AUC value
研究概览
简要总结
Ten percent of American adults, more than 20 million people, have chronic kidney disease, which in the advanced state of end stage renal disease is most desirably and cost-effectively treated by kidney transplantation. However, 20-30% of transplanted kidneys fail in living recipients by 10 years, owing largely to insufficient monitoring methods. The goal of the proposed research is to improve noninvasive kidney transplant monitoring using a new ultrasound-based imaging method called Viscoelastic Response (VisR) ultrasound.
详细描述
Renal transplantation is the most desirable and cost effective treatment for end stage renal disease, but 20-30% of allografts fail in living recipients by 10 years, and prolonging graft health is one of the major unmet needs for transplant patients. Although graft health is extended by preemptive treatments that prevent irreversible damage, intervention is inadequately motivated by current transplant monitoring methods. Noninvasive methods, including changes in serial serum creatinine levels, lack sensitivity and specificity. In the absence of reliable noninvasive biomarkers, invasive biopsy remains the standard for assessing transplant health, but surveillance or "protocol" biopsies are associated with morbidity and cost and are therefore controversial in stable, unsensitized patients. The lack of a demonstrated, noninvasive biomarker for allograft health - one that identifies early graft degeneration with sufficient sensitivity and specificity to motivate appropriate biopsy and enable timely intervention - represents a major gap in renal transplant management.
To fill this gap, the proposed re-search aims to demonstrate Viscoelastic Response (VisR) ultrasound, a novel acoustic radiation force (ARF)-based technology that noninvasively interrogates the viscoelastic properties of tissue, for monitoring renal allograft health. The investigators hypothesize that in vivo VisR ultrasound delineates renal allograft dysfunction earlier and with greater sensitivity and specificity than serum creatinine concentration in renal allograft recipients.
To test this hypothesis, the investigators will determine which VisR outcome metrics detect renal allograft dysfunction clinically by performing serial VisR imaging in living donor (LD) and deceased donor (DD) transplant recipients. Imaging results will be compared to biopsy findings to determine VisR's ability to detect dysfunction. The investigators will also compare serial VisR and serum creatinine outcomes in terms of ability to detect renal allograft dysfunction and the timeliness of detection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least 18 years of age
- •Selected by treating physician to be in need of renal transplant surgery
- •Ability to provide informed consent
- •Ability to communicate with pertinent staff
- •Ability to understand and comply with study requirements
排除标准
- •Inability to provide valid consent
- •Inability to communicate with pertinent staff
- •Inability to remain motionless for at least 20 minutes
- •Renal transplant deeper than 4 cm
结局指标
主要结局
VisR AUC value
时间窗: at time of clinically indicated biopsy
AUC for VisR to detect positive biopsy finding (indiscriminate of type)
次要结局
- AUC for the ability of change in serum creatinine level to detect positive biopsy finding(at time of clinically indicated biopsy)
- AUC for the ability of change in VisR Tau value to detect positive biopsy finding(at time of clinically indicated biopsy)
- AUC for the ability of change in VisR Relative Elasticity value to detect positive biopsy finding(at time of clinically indicated biopsy)
- AUC for the ability of change in VisR Relative Viscosity value to detect positive biopsy finding(at time of clinically indicated biopsy)
- Change in serum creatinine level(1-2 weeks, 4 weeks, 2 months, 3 months, 6 months, 9 months, 12 months, and then every 4 months after transplantation until time of clinically indicated biopsy or 3 years after transplantation, which ever comes first)
- Change in VisR Tau value(1-2 weeks, 4 weeks, 2 months, 3 months, 6 months, 9 months, 12 months, and then every 4 months after transplantation until time of clinically indicated biopsy or 3 years after transplantation, which ever comes first)
- Change in VisR Relative Elasticity value(1-2 weeks, 4 weeks, 2 months, 3 months, 6 months, 9 months, 12 months, and then every 4 months after transplantation until time of clinically indicated biopsy or 3 years after transplantation, which ever comes first)
- Change in VisR Relative Viscosity value(1-2 weeks, 4 weeks, 2 months, 3 months, 6 months, 9 months, 12 months, and then every 4 months after transplantation until time of clinically indicated biopsy or 3 years after transplantation, which ever comes first)
- AUC for the ability of VisR-derived Tau to detect positive biopsy finding(at time of clinically indicated biopsy)
- AUC for the ability of VisR-derived Relative Elasticity to detect positive biopsy finding(at time of clinically indicated biopsy)
- AUC for the ability of VisR-derived Relative Viscosity to detect positive biopsy finding(at time of clinically indicated biopsy)