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

8. Juni 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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)

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

40

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Roderick J Tan, MD, PHD
  • Telefonnummer: 4126244008
  • E-Mail: tanrj@upmc.edu

Studieren Sie die Kontaktsicherung

Studienorte

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • University of Pittsburgh Medical Center
        • Kontakt:
          • Roderick J Tan, MD, PHD
          • Telefonnummer: 4126244008
          • E-Mail: tanrj@upmc.edu
        • Kontakt:
        • Unterermittler:
          • Kang Kim, PHD
        • Unterermittler:
          • George F Viriya, MD
        • Hauptermittler:
          • Roderick J Tan, MD, PHD
        • Unterermittler:
          • Mohit Madken, MD
        • Unterermittler:
          • Jihoon Park, MD, PHD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Kidney vascularity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Kidney blood vessel tortuosity
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2028

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

8. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

June 1, 2026 until June 30, 2030

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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