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

NCT ID: NCT06751498

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Cell Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shao Pengfei

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shao Pengfei

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Nanjing, Jiangsu, China

Site Status RECRUITING

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

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shao Pengfei, Professor

Role: CONTACT

+8613851925825

Miao Haoqi, Postgraduate

Role: CONTACT

+8613276636957

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shao Pengfei, Professor

Role: primary

+8613851925825

Miao Haoqi, Postgraduate

Role: backup

+8613276636957 ext. [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-SR-710

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.