Actively Recruiting

Age: 18Years +
All Genders
NCT07294859

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

Led by Jinling Hospital, China · Updated on 2025-12-19

285

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fully understood and voluntarily signed the informed Consent Form (ICF)
  • Age over 18 years at the time of signing the informed consent form
  • Preoperative estimated glomerular filtration rate (eGFR) greater than 45 ml/min/1.73m2
  • Scheduled for either radical nephrectomy or partial nephrectomy as decided with the clinician
  • ECOG performance status score between 0 and 2
  • Willing and able to comply with study visits, treatments, laboratory tests, and procedures
Not Eligible

You will not qualify if you...

  • Patients with a solitary kidney or severe insufficiency in the other kidney (eGFR less than 15 ml/min/1.73m2)
  • Preoperative dependence on renal replacement therapy such as dialysis
  • Incomplete nephrectomy during surgery
  • Presence of lymph node metastasis, distant metastasis, or venous tumor thrombus
  • Healthy kidney previously treated with radiotherapy, ablation, or surgery
  • History of allergy to ultrasound contrast agents
  • Contraindications to contrast-enhanced ultrasound including right-to-left shunt or severe pulmonary hypertension
  • Hemodynamic instability such as persistent low blood pressure, uncontrollable heart failure, active bleeding, low hemoglobin, or low platelet count
  • Structural or functional abnormalities of the urinary system that cannot be quickly corrected, including duplicate kidneys, polycystic kidneys, horseshoe kidneys, isolated kidneys, significant renal artery stenosis, urinary obstruction, prior kidney surgery, or long-term urinary catheter use
  • Any diseases limiting life expectancy to less than six months
  • Participation in another clinical study within 30 days before enrollment or concurrently

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

L

Le Qu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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