The Value of a Convolutional Neural Network-Based Renal Artery Perfusion Model in Predicting Renal Function After Partial Nephrectomy: A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Renal Cell Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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?
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.
Primary outcome measures
- GFR of ipsilateral and contralateral kidneys [Time frame: 3 months after surgery]
- volume of ipsilateral kidney [Time frame: 3 months after surgery]
Secondary outcome measures (1)
- Postoperative total renal function(eGFR) [Time frame: 24 hours, 1 month, 3 months, 6 months, 1 year after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's H — Nanjing
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's H — Nanjing
Identifiers
NCT: NCT06751498 · 2024-SR-710