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Clinical Trials in China / NCT07294859
Recruiting Observational

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

NCT07294859 · tracked via the Priya Life Science China tracker
Sponsor
Jinling Hospital, China
Phase
Observational
Started
2025-09-01
Last updated
2025-12-19

Condition(s) studied

NephrectomyRenal Cell CancerAKI - Acute Kidney Injury

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • new baseline estimates glomerular filtration rate(NB-eGFR) — 12 months after nephrectomy
    NB-eGFR is defined as multiple eGFR tests conducted within 3 to 12 months after surgery, and the last eGFR measurement value within this time window (the calculation of eGFR uses the corrected CKD-EPI formula)
  • Rec-Ischemia — 12 months after partial nephrectomy
    This outcome is mainly applicable to patients undergoing partial nephrectomy. It is defined as the ratio of the ipsilateral GFR retention rate to the renal parenchymal retention rate (PPVP), that is, the degree of functional recovery of the retained renal parenchyma per unit. The calculation formula is Rec-Ischemia= ipsilateral GFR retention rate /PPVP×100%13. Ipsilateral GFR retention rate = postoperative ipsilateral GFR/ preoperative ipsilateral GFR×100%, PPVP= postoperative ipsilateral renal parenchymal volume/preoperative ipsilateral renal parenchymal volume ×100%. The predicted ipsilateral GFR after surgery = the total postoperative GFR× the expected retained SRF of the affected kidney. The expected retained SRF of the affected kidney = the parenchymal volume of the affected kidney/(the parenchymal volume of the affected kidney + the parenchymal volume of the contralateral kidney).

Trial sites (1)

FacilityCityRegionStatus
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University Nanjing Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07294859 on ClinicalTrials.gov ↗ ← All trials in China