The Value of a Convolutional Neural Network-Based Renal Artery Perfusion Model in Predicting Renal Function After Partial Nephrectomy: A Prospective Study

April 14, 2025 updated by: Shao Pengfei

The Value of a Renal Artery Perfusion Model Based on Convolutional Neural Network in Predicting Renal Function After Partial Nephrectomy: A Prospective, Single-Center Study

The goal of this observational study is to develop a CNN-based machine module to predict postoperative fractional renal function in people who are proposed to undergo partial nephrectomy. The main question it aims to answer is:

• Does this machine learning model accurately predict renal function after partial nephrectomy?

Study Overview

Status

Recruiting

Conditions

Renal Cell Cancer

Detailed Description

This prospective study is conducted to predict postoperative fractional renal function using the perfusion deficit method from a preoperatively established renal arterial perfusion model for people who are proposed to undergo partial nephrectomy. In this study, this prediction method will be compared with the true missing values of renal units on nuclear renal function, eGFR, and CTA. This study aims to evaluate the feasibility of applying the CNN-based model in predicting postoperative renal function after partial nephrectomy and provide high-level clinical evidence for the preoperative integrated diagnostic and treatment process of renal tumors, especially in terms of the functional evaluation.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shao Pengfei, Professor
Phone Number: +8613851925825
Email: spf032@hotmail.com

Study Contact Backup

Name: Miao Haoqi, Postgraduate
Phone Number: +8613276636957
Email: mhq@stu.njmu.edu.cn

Study Locations

China
- Jiangsu
  - Nanjing, Jiangsu, China, 210000
    - Recruiting
    - The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
  - Nanjing, Jiangsu, China, 210036
    - Not yet recruiting
    - The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
    - Contact:
      
      Shao Pengfei, Professor
      
      Phone Number: +8613851925825
      
      Email: spf032@hotmail.com
    - Contact:
      
      Miao Haoqi, Postgraduate
      
      Phone Number: mhq@stu.njmu.e +8613276636957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

people with localized renal tumors scheduled for partial nephrectomy

Description

Inclusion Criteria:

people with stage cT1 renal tumors confirmed by preoperative CT or MR
people who are proposed to undergoing partial nephrectomy
localized renal tumors without lymph node and distant metastases as defined by NCCN guidelines
ECOG score of 0 or 1
Life expectancy greater than 10 years

Exclusion Criteria:

people with surgically unresectable lesions
people with Abnormal preoperative renal function, eGFR(estimated by CKD-EPI)<90ml/min/1.73m2
people who receive preoperative molecular targeted therapy, immunotherapy, chemotherapy
people with any contraindications to surgery
people who convert to radical nephrectomy during surgery
people who receive molecular targeted therapy, immunotherapy or chemotherapy during the postoperative follow-up period
people with serious systemic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GFR of ipsilateral and contralateral kidneys Time Frame: 3 months after surgery	3 months after surgery
volume of ipsilateral kidney Time Frame: 3 months after surgery	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Postoperative total renal function(eGFR) Time Frame: 24 hours, 1 month, 3 months, 6 months, 1 year after surgery	24 hours, 1 month, 3 months, 6 months, 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shao Pengfei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria