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Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function (MUST-D)

8 juni 2026 bijgewerkt door: Roderick Tan

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.

Studie Overzicht

Gedetailleerde beschrijving

Specific Aim 1: Utilize super-resolution ultrasound (SRU) to analyze tiny blood vessels in transplanted kidneys under very detailed imaging and evaluate kidney allografts and predict post-transplantation function.

Delayed graft function (DGF) is a common complication that can happen soon after a kidney transplant and may lead to longer recovery times and other health problems. Kidney biopsies are typically required to find the cause, which are invasive procedures. Current imaging tests cannot clearly show the tiny blood vessel changes inside the transplanted kidney that may contribute to the development of DGF.

Hypothesis: Investigators hypothesize that SRU can noninvasively predict DGF outcomes by measuring changes in the structure of tiny kidney blood vessels and the blood flow within them.

Approach:

Aim 1a: Compare SRU-derived measures of renal microvasculature-including microvascular density, tortuosity, and cortical perfusion-between patients who develop DGF and those with uncomplicated graft function.

Aim 1b: Correlate SRU parameters with clinical outcomes at 30 and 90 days post-transplant, as determined from inpatient and outpatient data within the electronic medical record.

Experimental Plan. Allograft SRU will be performed in 20 renal allograft recipient patients up to 14 days after transplant (n=10 with DGF, n=10 without DGF). Patients will be identified and recruited from within UPMC. After injection with Definity, SRU images and measurements will be obtained as described elsewhere in this protocol. Measures are noninvasive, with the transducer applied to the body surface over the allograft. Measurements will be compared between the two groups, and correlations made with eGFR at 30 and 90 days, total days of dialysis, resistive indices, and interstitial fibrosis/tubular atrophy (IFTA) on the standard 3-month protocol biopsy.

Anticipated Results, Potential Pitfalls, and Future Directions. Investigators expect that renal blood volume and microvessel density will be higher in patients with functioning grafts, and that these parameters will be positively correlated with better outcomes, demonstrating that SRU is a promising and noninvasive prognostic tool.

Expected Outcomes and Impact: Investigators anticipate that SRU will identify microvascular densities predictive of DGF, providing a novel, noninvasive biomarker to guide post-transplant management. Successful completion of this aim will establish SRU as a clinically useful tool to reduce reliance on invasive biopsy and improve early allograft evaluation.

Specific Aim 2: Utilize super-resolution ultrasound (SRU) to evaluate early microvascular changes in high-KDPI kidneys up to 14 days after transplantation to predict early graft function.

Rationale: Donor kidneys with a high Kidney Donor Profile Index (KDPI) are often discarded due to their perceived risk of poor function, despite limited physiologic data on their microvascular integrity. Early post-transplant microvascular alterations may serve as critical indicators of graft viability and short-term function.

Hypothesis: Investigators hypothesize that SRU-detected microvascular changes occurring within the first 48 hours after transplantation can predict early transplanted kidney function and distinguish between high- and low-KDPI kidneys.

Experimental Plan:

Investigators will perform SRU imaging within 14 days of transplantation in kidney allograft recipients, using the same SRU parameters described in Aim 1. Investigators will compare SRU-derived measures such as structure, size, characteristics, and blood flow -between two groups: recipients of high-risk kidneys (KDPI >75; n = 10) and recipients of more optimal kidneys (KDPI <35; n = 10). SRU findings will be correlated with key clinical outcomes, including the incidence of delayed graft function (DGF), need for dialysis, measures of kidney function at 30 and 90 day marks, and the degree of scarring of the functional units of the kidney observed on 90-day protocol biopsies.

Anticipated Results, Potential Pitfalls, and Future Directions:

Investigators anticipate that kidneys with higher KDPI values will demonstrate reduced vascular density and perfusion within 48 hours post-transplant, and that these findings will correlate with inferior 30- and 90-day outcomes. If no significant differences or correlations are observed, investigators will reconsider the utility of the 48-hour timepoint in future studies or examine whether recipient-specific factors (e.g., age, hemodynamic status, blood pressure) influence SRU measurements. Findings from this aim will inform whether SRU can serve as an early, noninvasive measurement of transplanted kidney quality and may challenge current allocation practices that exclude high-KDPI kidneys (high-risk of suboptimal functioning kidneys)

Studietype

Observationeel

Inschrijving (Geschat)

40

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Roderick J Tan, MD, PHD
  • Telefoonnummer: 4126244008
  • E-mail: tanrj@upmc.edu

Studie Contact Back-up

Studie Locaties

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • University of Pittsburgh Medical Center
        • Contact:
          • Roderick J Tan, MD, PHD
          • Telefoonnummer: 4126244008
          • E-mail: tanrj@upmc.edu
        • Contact:
        • Onderonderzoeker:
          • Kang Kim, PHD
        • Onderonderzoeker:
          • George F Viriya, MD
        • Hoofdonderzoeker:
          • Roderick J Tan, MD, PHD
        • Onderonderzoeker:
          • Mohit Madken, MD
        • Onderonderzoeker:
          • Jihoon Park, MD, PHD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult patients with end stage kidney disease who are receiving deceased donor kidney allograft transplants who meet the inclusion and exclusion criteria

Beschrijving

Inclusion Criteria:

For stage 1 of the study:

  1. We will enroll patients ≥18 years of age
  2. Patients who received a kidney transplant 2a. Patients requiring dialysis in the first 14 days after transplant 2b. Patients with working allografts not requiring dialysis (control group)

For stage 2 of the study

  1. We will enroll patients at least 18 years of age or older
  2. Patients who received a kidney transplant 2a. Patients who received kidney transplants from low KDPI kidneys (KDPI < 35) 2b. Patients who received kidney transplants from high KDPI kidneys (KDPI > 75)

Exclusion Criteria:

  1. BMI > 40
  2. Inability to provide informed consent
  3. Pregnant woman
  4. Breastfeeding women
  5. Hypersensitivity to perfluten lipid microsphere and components including polyethylene glycol (PEG)
  6. Unstable cardiopulmonary condition (acute myocardial infarction, acute coronary artery symptoms, worsening or unstable congestive heart failure, serious ventricular arrhythmias).
  7. Known history of cardiac shunts
  8. Patients who have known sickle cell disease or trait

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
High KDPI
Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with High KDPI allografts
Super-resolution ultrasound using lipid microsphere contrast
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.
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.
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.
Low KDPI
Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with Low KDPI allografts
Super-resolution ultrasound using lipid microsphere contrast
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.
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.
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.
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.
Super-resolution ultrasound using lipid microsphere contrast
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.
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.
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.
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.
Super-resolution ultrasound using lipid microsphere contrast
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.
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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Kidney vascularity
Tijdsspanne: Less than 30 minutes
Assessment of total renal vascularity and measures of perfusion. Images obtained with the kidney ultrasound will be analyzed for total number of blood vessels and blood perfusion detected in different regions of the kidney.
Less than 30 minutes

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Kidney blood vessel tortuosity
Tijdsspanne: up to 30 minutes
While the total number of blood vessels may differ between subjects, it is also possible that the number of blood vessel branches may be different.
up to 30 minutes

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

8 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Patient data such as demographics, test results, medical chart data, and data acquired from imaging including vessel density, cortical perfusion, and vessel branching.

IPD-tijdsbestek voor delen

June 1, 2026 until June 30, 2030

IPD-toegangscriteria voor delen

Researchers with ideas for studies using our data may request it from the study PI.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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