Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study

Launched by SHAO PENGFEI · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how a new artificial intelligence (AI) tool can help surgeons during a type of kidney surgery called partial nephrectomy, which is used to remove part of the kidney affected by cancer. The AI tool creates a 3D model of the patient's kidney in real-time, which may help improve the surgery and make it safer and more efficient. The study is currently looking for participants aged 18 to 80 who have specific types of localized kidney tumors that are suitable for this minimally invasive surgery.

To be eligible for the trial, participants must have imaging tests (like a CT or MRI) showing certain types of kidney tumors and must be able to give consent to join the study. Participants will receive thorough counseling about the surgery and the study before making a decision. If you join, you can expect close monitoring and follow-up for 12 months after the surgery to assess how well the AI tool works. This trial aims to enhance surgical outcomes and provide valuable insights into the use of technology in cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ages 18-80 years, regardless of gender
• • Written informed consent obtained from the patient or legally authorized representative after full protocol disclosure
• • Preoperative imaging (CT/MRI) confirming clinical stage T1a or select T1b renal tumors suitable for partial nephrectomy (R.E.N.A.L. nephrometry score ≤10)
• • Localized renal tumors without lymph node/distant metastasis per NCCN Guidelines® (v2023)
• • Elective minimally invasive partial nephrectomy (laparoscopic/robotic) after comprehensive surgical counseling
• Exclusion Criteria:
• • Multifocal renal tumors (bilateral or unilateral)
• • Prior systemic anticancer therapy (targeted agents/immunotherapy/chemotherapy) within 6 months
• • Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)
• • Intraoperative conversion to radical nephrectomy or open approach
• • Postoperative adjuvant therapy during protocol-defined follow-up (12 months)
• • Major comorbidities (e.g., NYHA class III/IV heart failure, eGFR \<30 mL/min/1.73m²) affecting outcome assessment
• • Concurrent enrollment in interventional clinical trials
• • Investigator-determined ineligibility based on risk-benefit analysis