Contrast-enhanced ultrasound and super-resolution imaging to predict kidney function after nephrectomy

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

This project will test whether special ultrasound scans—contrast-enhanced ultrasound and super-resolution imaging—can help predict kidney function and the risk and recovery of acute kidney injury in adults having partial or radical nephrectomy for kidney cancer.

Quick facts

• Study type: Observational
• Enrollment: 285 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07294859 on ClinicalTrials.gov

What this trial studies

Researchers will enroll about 285 adults with renal cell carcinoma who are scheduled for partial or radical nephrectomy and perform contrast-enhanced ultrasound (CEUS) and super-resolution imaging (SRI) before and at multiple time points after surgery. They will quantify microcirculation and microvascular structure in the operated kidney and compare those measures with the contralateral healthy kidney over time. Primary outcomes include long-term renal function (new baseline eGFR after radical nephrectomy and recovery from ischemia after partial nephrectomy) and the occurrence, severity, and early recovery of postoperative acute kidney injury (AKI). Imaging biomarkers will be combined with clinical variables to build predictive models tailored to different surgical methods.

Who should consider this trial

Good fit: Adults (≥18 years) with renal cell carcinoma scheduled for partial or radical nephrectomy who have preoperative eGFR >45 ml/min/1.73m2 and ECOG performance status 0–2 and can attend study visits.

Not a fit: Patients with a solitary kidney, severe contralateral renal impairment (eGFR <15 ml/min/1.73m2), preoperative dialysis dependence, metastatic disease, or who cannot complete the planned nephrectomy are unlikely to benefit from the study findings.

Why it matters

Potential benefit: If successful, these imaging biomarkers could help clinicians identify patients at high risk for postoperative AKI or long-term decline in kidney function so care can be personalized to prevent or limit damage.

How similar studies have performed: Contrast-enhanced ultrasound has shown promise in smaller prior studies for characterizing renal perfusion and AKI risk, but combining CEUS with super-resolution imaging for postoperative prediction is novel and not yet proven.

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.

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Le Qu

Conditions Nephrectomy; Renal Cell Cancer; AKI - Acute Kidney Injury