Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Roderick Tan
Study ID
NCT07645599
Status
Not Yet Recruiting

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Conditions

  • End Stage Chronic Renal Failure
  • Microvascular Changes
  • Microvascular Circulation
  • Renal Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound contrast agent (Contrast-enhanced ultrasound) — DIAGNOSTIC_TEST
    Super-resolution ultrasound using lipid microsphere contrast
  • Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) — DRUG
    Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
  • Lumason® contrast agent — DRUG
    Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
  • DEFINITY® — DRUG
    Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.

Study Details

This pilot study is testing a new ultrasound imaging method called Super-Resolution Ultrasound (SRU) to look at blood flow and tiny blood vessels in transplanted kidneys in very detailed images after kidney transplant surgery. The goal is to see whether changes in the kidney's small blood vessels can help predict how well the transplanted kidney will work early after transplant, including whether delayed graft function may occur. Investigators hope this technique can become a safe, noninvasive way to evaluate transplanted kidneys without needing as many invasive biopsies. It may also help doctors better assess donor kidneys at higher-risk of suboptimal functioning.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: High KDPI
    Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with High KDPI allografts
  • Arm: Low KDPI
    Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with Low KDPI allografts
  • Arm: Delayed Graft Function
    Adult end stage kidney disease patients who received a recent deceased donor kidney transplant who require renal replacemen therapy within 2 weeks after transplant.
  • Arm: Non-delayed Graft Function
    Adult end stage kidney disease patients who received a recent deceased donor kidney transplant who do not require renal replacemen therapy within 2 weeks after transplant.

Primary Outcome Measure

Kidney vascularity [ Time Frame: Less than 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
George F Viriya, MD
[email protected]
9177480056
Roderick J Tan, MD, PHD
[email protected]
4126244008
Kang Kim, PHD (SUB_INVESTIGATOR)
George F Viriya, MD (SUB_INVESTIGATOR)
Roderick J Tan, MD, PHD (PRINCIPAL_INVESTIGATOR)
Mohit Madken, MD (SUB_INVESTIGATOR)
Jihoon Park, MD, PHD (SUB_INVESTIGATOR)

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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