Clinical trial NCT06751498: The Value of a Convolutional Neural Network-Based Renal Artery Perfusion Model in Predicting Renal Function After Partial Nephrectomy: A Prospective Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cell Cancer
Keywords: Articicial Intelligence
convolutional neural network
renal arterial perfusion model
partial nephrectomy
fractional renal function
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with localized renal tumors scheduled for partial nephrectomy

Brief summary: 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.

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

Primary outcomes:
measure: GFR of ipsilateral and contralateral kidneys
timeFrame: 3 months after surgery
measure: volume of ipsilateral kidney
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Postoperative total renal function(eGFR)
timeFrame: 24 hours, 1 month, 3 months, 6 months, 1 year after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
state: Jiangsu
Study officials:
References: