Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function

NCT07645599 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: STUDY25100091
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

renal allograft; kidney allograft; kidney transplant; super-resolution ultrasound; lipid microspheres; renal microvasculature; kidney microvasculature; delayed graft function; Kidney Donor Profile Index; deceased donor kidney transplant

Outcome Measures

Primary Outcomes (1)

• Kidney vascularity

  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

Secondary Outcomes (1)

• Kidney blood vessel tortuosity

  up to 30 minutes

Study Arms (4)

High KDPI

Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with High KDPI allografts

Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY®

Low KDPI

Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with Low KDPI allografts

Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY®

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.

Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY®

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.

Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY®

Interventions

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.

Delayed Graft Function; High KDPI; Low KDPI; Non-delayed Graft Function

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.

Delayed Graft Function; High KDPI; Low KDPI; Non-delayed Graft Function

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.

Delayed Graft Function; High KDPI; Low KDPI; Non-delayed Graft Function

Ultrasound contrast agent (Contrast-enhanced ultrasound) DIAGNOSTIC_TEST

Super-resolution ultrasound using lipid microsphere contrast

Delayed Graft Function; High KDPI; Low KDPI; Non-delayed Graft Function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• For stage 1 of the study:
• We will enroll patients ≥18 years of age
• 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
• We will enroll patients at least 18 years of age or older
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Roderick Tan: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Delayed Graft Function

Interventions

FS 069; perflutren

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roderick J Tan, MD, PHD

CONTACT

4126244008; Tanrj@upmc.edu

George F Viriya, MD

CONTACT

viriyagf@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: June 1, 2026 until June 30, 2030
• Access Criteria: Researchers with ideas for studies using our data may request it from the study PI.

Locations

US (1)