VisR Ultrasound for Noninvasively Monitoring Renal Allograft Health
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | June 16, 2016 |
| End Date: | February 2021 |
| Contact: | Melrose W Fisher, R.N. |
| Email: | mwfisher54@gmail.com |
| Phone: | 919-819-9054 |
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.
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.
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.
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.
Inclusion Criteria:
1. At least 18 years of age
2. Selected by treating physician to be in need of renal transplant surgery
3. Ability to provide informed consent
4. Ability to communicate with pertinent staff
5. Ability to understand and comply with study requirements
Exclusion Criteria:
1. Inability to provide valid consent
2. Inability to communicate with pertinent staff
3. Inability to remain motionless for at least 20 minutes
4. Renal transplant deeper than 4 cm
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-819-9054
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