Actively Recruiting
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
Led by Jinling Hospital, China · Updated on 2025-12-19
285
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how advanced imaging techniques, specifically Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI), can predict kidney function outcomes in patients with renal cell carcinoma undergoing either partial or radical nephrectomy. This prospective cohort study focuses on whether these imaging methods can forecast long-term kidney function and the occurrence, severity, and early recovery from postoperative acute kidney injury (AKI). The study aims to provide new imaging biomarkers to support personalized care and early treatment decisions after nephrectomy. Participants will undergo CEUS and SRI examinations before surgery and at specific times afterward to visualize kidney blood flow and microvascular structures. The study will monitor changes in both the affected and healthy kidneys. Blood and urine samples will be collected during hospitalization for kidney function tests. Follow-up visits will occur at 1, 3, 6, 9, and 12 months post-surgery, including imaging assessments like CT or ultrasound to track recovery. During the study, researchers will collect clinical data, imaging results, and laboratory tests to analyze the relationship between imaging parameters and kidney function outcomes. The primary outcomes include measuring new baseline estimated glomerular filtration rate (eGFR) and recovery from ischemia 12 months after surgery. The study will also observe kidney blood flow and microvascular density changes over time to understand their link to AKI and long-term kidney health.
CONDITIONS
Brief Title
Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy
Who Can Participate
Eligibility Criteria
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 partial or radical nephrectomy as decided by clinician and patient
- ECOG performance status score of 0 to 2
- Willing and able to comply with study visits, treatments, laboratory tests, and procedures
You will not qualify if you...
- Solitary kidney or severe contralateral renal insufficiency (eGFR less than 15 ml/min/1.73m2)
- Reliance on renal replacement therapy such as dialysis before surgery
- Failure to complete planned nephrectomy during operation
- 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, or bleeding tendency with low hemoglobin or platelet counts
- Structural or functional abnormalities of the urinary system that cannot be corrected quickly
- Diseases limiting life expectancy to less than six months
- Participation in another clinical study within 30 days prior to enrollment or concurrent participation in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Preoperative period
Participants undergo contrast-enhanced ultrasound and super-resolution imaging to assess renal microcirculation and microvascular structure before nephrectomy.
1 to 2 visits depending on surgical scheduling
Duration - Surgery day and immediate post-operative period
Participants undergo partial or radical nephrectomy with immediate post-operative monitoring and imaging assessments.
1 visit (in-person) on surgery day plus immediate post-operative assessments
Duration - Up to 12 months after surgery
Participants are followed longitudinally with repeated imaging and clinical assessments to monitor renal function changes and predict outcomes after nephrectomy.
Multiple visits over 12 months including imaging and clinical assessments
Trial Site Locations
Total: 1 location
1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
L
Le Qu
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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