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NCT Number: NCT06751498

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

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. GFR of ipsilateral and contralateral kidneys

    Time frame: 3 months after surgery

  2. volume of ipsilateral kidney

    Time frame: 3 months after surgery

Secondary outcomes

  1. Postoperative total renal function(eGFR)

    Time frame: 24 hours, 1 month, 3 months, 6 months, 1 year after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Miao Haoqi, Postgraduate

CONTACT

[email protected]

+8613276636957

Shao Pengfei, Professor

CONTACT

[email protected]

+8613851925825

Sponsors and collaborators

Lead sponsor

Shao Pengfei

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 30, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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