Renal Cell CancerNCT06751498
The Value of a Convolutional Neural Network-Based Renal Artery Perfusion Model in Predicting Renal Function After Partial Nephrectomy: A Prospective Study
An observational study of Renal Cell Cancer, run by Shao Pengfei at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Cancer
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2025to 1 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with localized renal tumors scheduled for partial nephrectomy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210000
- Not yet recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210036
Shao Pengfei, Professor, +8613851925825, spf032@hotmail.com
Miao Haoqi, Postgraduate, +8613276636957 ext. mhq@stu.njmu.e
About this 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
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?
Read the 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.
- Conditions
- Renal Cell Cancer
- Keywords
- Articicial Intelligence, convolutional neural network, renal arterial perfusion model, partial nephrectomy, fractional renal function
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR of ipsilateral and contralateral kidneys
Measured: 3 months after surgery
volume of ipsilateral kidney
Measured: 3 months after surgery
Secondary outcomes (1)
Postoperative total renal function(eGFR)
Measured: 24 hours, 1 month, 3 months, 6 months, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shao Pengfei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shao Pengfei, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751498
- Sponsor's protocol ID
- 2024-SR-710
- Status last verified
- Apr 2025
- First submitted
- 25 Dec 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06751498
- Acronym / sponsor ID
- 2024-SR-710
- Conditions
- Renal Cell Cancer
- Keywords
- Articicial Intelligence, convolutional neural network, renal arterial perfusion model, partial nephrectomy, fractional renal function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shao PengfeiUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with localized renal tumors scheduled for partial nephrectomy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GFR of ipsilateral and contralateral kidneys
Time frame: 3 months after surgery
volume of ipsilateral kidney
Time frame: 3 months after surgery
1 secondary outcome
Postoperative total renal function(eGFR)
Time frame: 24 hours, 1 month, 3 months, 6 months, 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Cancer, run by Shao Pengfei at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shao Pengfei, Professor (+8613851925825, spf032@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR of ipsilateral and contralateral kidneys (time frame: 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.