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VisR Ultrasound for Noninvasively Monitoring Renal Allograft Health

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ClinicalTrials.gov Identifier: NCT03079882
Recruitment Status : Suspended (Suspended due to COVID-19 risks)
First Posted : March 15, 2017
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease
Renal Transplant Failure

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VisR Ultrasound for Noninvasively Monitoring Renal Allograft Health
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Living Donor Recipients
Recipients of renal transplants with the transplanted organ originating from living donors
Deceased Donor Recipients
Recipients of renal transplants with the transplanted organ originating from deceased donors



Primary Outcome Measures :
  1. VisR AUC value [ Time Frame: at time of clinically indicated biopsy ]
    AUC for VisR to detect positive biopsy finding (indiscriminate of type)


Secondary Outcome Measures :
  1. AUC for the ability of change in serum creatinine level to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Receiver operating characteristic (ROC) curve analysis will be performed using pathology findings as the gold standard. From the ROC curve, AUC will be calculated.

  2. AUC for the ability of change in VisR Tau value to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Receiver operating characteristic (ROC) curve analysis will be performed using pathology findings as the gold standard. From the ROC curve, AUC will be calculated.

  3. AUC for the ability of change in VisR Relative Elasticity value to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Receiver operating characteristic (ROC) curve analysis will be performed using pathology findings as the gold standard. From the ROC curve, AUC will be calculated.

  4. AUC for the ability of change in VisR Relative Viscosity value to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Receiver operating characteristic (ROC) curve analysis will be performed using pathology findings as the gold standard. From the ROC curve, AUC will be calculated.

  5. Change in serum creatinine level [ Time Frame: 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 ]
    serum creatine will be measured serially, consistent with clinical indication, and change in level from time point to time point will be recorded.

  6. Change in VisR Tau value [ Time Frame: 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 ]
    VisR Tau will be measured serially, and change in values from time point to time point will be recorded.

  7. Change in VisR Relative Elasticity value [ Time Frame: 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 ]
    VisR Relative Elasticity will be measured serially, and change in values from time point to time point will be recorded.

  8. Change in VisR Relative Viscosity value [ Time Frame: 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 ]
    VisR Relative Viscosity will be measured serially, and change in values from time point to time point will be recorded.

  9. AUC for the ability of VisR-derived Tau to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Tau represents the relaxation time constant for constant stress in a Voigt material and reflects the ratio of viscous to elastic properties of the kidney in the examined region.

  10. AUC for the ability of VisR-derived Relative Elasticity to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Relative elasticity qualitatively represents the tissue elastic modulus relative to the applied force amplitude

  11. AUC for the ability of VisR-derived Relative Viscosity to detect positive biopsy finding [ Time Frame: at time of clinically indicated biopsy ]
    Relative viscosity qualitatively represents the tissue viscous modulus relative to the applied force amplitude



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This unblinded, open-label, exploratory study will be conducted in 100 consecutively evaluable patients (50 with renal allografts from living donors and 50 with allografts from deceased donors). Patients will be recruited from those already undergoing renal transplant surgery for end stage renal disease based on the standard of care at UNC Hospitals. Potential study participants will be patients 18 years of age or older who have been selected by their treating physician to be in need of renal transplant surgery for end stage renal disease at University of North Carolina Hospitals' Nephrology Transplant clinic. Participants will be enrolled in two groups, as living or deceased donor recipients. There will be no intervention beyond VisR ultrasound imaging.
Criteria

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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079882


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Caterina M Gallippi, Ph.D. University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03079882    
Other Study ID Numbers: 15-2934
1R01DK107740 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
Ultrasound
Viscoelasticity
Viscoelastic Response (VisR) Ultrasound