Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy

Official title

A Prospective Clinical Study on the Predictive Value of CEUS and Super-resolution Imaging Technology for Renal Function Outcome in Patients After Partial or Radical Nephrectomy

Overview

The goal of this prospective cohort study is to evaluate the predictive value of Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI) technologies regarding renal function outcomes in patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy. The main questions it aims to answer are: Can quantitative parameters of renal microcirculation and microvascular structure derived from CEUS and SRI predict long-term renal function (defined as New Baseline eGFR for radical nephrectomy and Recovery from Ischemia for partial nephrectomy)? Can these imaging parameters accurately predict the occurrence, severity, and early recovery of postoperative acute kidney injury (AKI)? Researchers will monitor the dynamic evolution of renal blood flow and microvascular density by comparing the affected kidney to the contralateral healthy kidney before and after surgery to see if these biomarkers correlate with clinical outcomes. Participants will: Undergo CEUS and SRI examinations before surgery and at specific time points after surgery (e.g., within 7 days) to visualize renal microvasculature. Provide blood and urine samples for standard laboratory tests (such as serum creatinine and Cystatin C) to assess kidney function during hospitalization. Attend follow-up visits at 1, 3, 6, 9, and 12 months post-surgery to monitor long-term renal recovery and complete necessary imaging assessments (CT or Ultrasound).

Detailed description

This study is a prospective cohort study aimed at evaluating the predictive value of contrast-enhanced ultrasound and super-resolution imaging techniques for renal function outcomes in patients after nephrectomy. The study intends to include approximately 285 patients with renal cell carcinoma who are scheduled to undergo partial nephrectomy or radical nephrectomy. The core of this study is to non-invasive and quantitatively monitor the microcirculation perfusion (such as hemodynamic parameters) and microvascular structure (such as microvascular density and glomerular density) of the affected and healthy kidneys at multiple time points before and after the operation by applying contrast-enhanced ultrasound and super-resolution imaging techniques, and simultaneously collect clinical data.

The main contents of this study include: longitudinal observation of the dynamic evolution patterns of renal microcirculation parameters before and after the operation; Analyze the correlations between these imaging parameters and the occurrence, severity and prognosis of postoperative acute kidney injury, and simultaneously explore the association between the occurrence and development of early AKI and long-term renal function changes; Ultimately, the goal is to combine predictive imaging parameters with traditional clinical variables (such as age, preoperative renal function, etc.) to construct integrated mathematical models for different surgical methods (partial nephrectomy and radical nephrectomy), in order to accurately predict the early (postoperative acute kidney injury) and long-term renal function (such as new baseline estimated glomerular filtration rate) of patients. Meanwhile, considering the compensatory function of contralateral renal function after PN, Rec-Ischemia was adopted as the primary endpoint indicator to evaluate the changes of ipsilateral postoperative renal function in patients after PN. This study is expected to provide innovative imaging biomarkers and decision support for individualized management and early intervention of renal function after nephrectomy.

Primary outcome measures

• new baseline estimates glomerular filtration rate(NB-eGFR) [Time frame: 12 months after nephrectomy]
• Rec-Ischemia [Time frame: 12 months after partial nephrectomy]

Eligibility criteria

Inclusion criteria

• Fully understood and voluntarily signed the informed Consent Form (ICF);
• Age: > 18 (at the time of signing the informed consent form); Gender is not limited.
• Preoperative eGFR > 45ml/min/1.73m2 (corrected CKD-EPI formula);
• After the clinician formulates the treatment plan and communicates with the patient, they decide whether to perform radical nephrectomy or partial nephrectomy.
• ECOG score: 0-2 points;
• Be willing and able to abide by the visits, treatments, laboratory tests and other procedures of the research plan.

Exclusion criteria

• Patients with solitary kidney or severe contralateral renal insufficiency (eGFR < 15ml/min/1.73m2);
• Preoperative reliance on renal replacement therapy (such as dialysis, etc.);
• Those who fail to complete the nephrectomy as planned during the operation;
• Patients with lymph node metastasis, distant metastasis or venous tumor thrombus;
• The healthy kidney has undergone radiotherapy, ablation or other surgeries.
• Have a history of allergy to ultrasound contrast agents;
• Have any contraindications for contrast-enhanced ultrasound, such as right-to-left shunt, severe pulmonary hypertension, etc.
• Patients with hemodynamic instability, including those with persistent hypotension (blood pressure < 90/60 MMHG), uncontrollable heart failure, active bleeding (such as gastrointestinal and cerebral hemorrhage, etc.), or those with a bleeding tendency and hemoglobin < 60g/L and/or platelet count < 50×109/L;
• Accompanied by structural abnormalities of the urinary system or functional abnormalities that cannot be corrected in a short time (such as duplicate kidneys, polycystic kidneys, horseshoe kidneys, isolated kidneys, renal artery stenosis > 50%, urinary tract obstruction, and previous history of kidney surgery, etc.), long-term indwelling of urinary catheters, etc.
• There are other diseases that limit life expectancy to less than six months;
• Previous (≤30 days before randomization) or concurrent participation in another clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing

Identifiers

NCT: NCT07294859 · DZQH-KYLL-25-37

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗