Renal Cell CancerNCT07020169
Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
A study testing an AI-based real-time image-guided kidney model system in people with Renal Cell Cancer, run by Shao Pengfei at 2 sites in China.
Trial summary
The goal of this study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy: Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Cancer
- What is being tested?
- an AI-based real-time image-guided kidney model system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2025to 1 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Ages 18-80 years, regardless of gender
- Written informed consent obtained from the patient or legally authorized representative after full protocol disclosure
- Preoperative imaging (CT/MRI) confirming clinical stage T1a or select T1b renal tumors suitable for partial nephrectomy (R.E.N.A.L. nephrometry score ≤10)
- Localized renal tumors without lymph node/distant metastasis per NCCN Guidelines® (v2023)
- Elective minimally invasive partial nephrectomy (laparoscopic/robotic) after comprehensive surgical counseling
Who cannot join
- Multifocal renal tumors (bilateral or unilateral)
- Prior systemic anticancer therapy (targeted agents/immunotherapy/chemotherapy) within 6 months
- Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)
- Intraoperative conversion to radical nephrectomy or open approach
- Postoperative adjuvant therapy during protocol-defined follow-up (12 months)
- Major comorbidities (e.g., NYHA class III/IV heart failure, eGFR <30 mL/min/1.73m²) affecting outcome assessment
- Concurrent enrollment in interventional clinical trials
- Investigator-determined ineligibility based on risk-benefit analysis
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
- Not yet recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210036
Pengfei Shao, Professor, +8613851925825, spf032@hotmail.com
Haoqi Miao, Postgraduate, +8613276636957, mhq@stu.njmu.edu.cn
- Recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210036
Pengfei Shao, Professor, +86 13851925825, spf032@hotmail.com
About this study
Official title: Artificial Intelligence-Driven 3D Kidney Model for Real-Time Augmented Reality and Surgical Navigation in Minimally Invasive (Robotic/Laparoscopic) Partial Nephrectomy: A Prospective Validation Study
The goal of this study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy:
- Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits?
Read the detailed description
This study aims to evaluate the feasibility of the AI-based real-time image-guided kidney model system in optimizing partial nephrectomy workflows. Patients scheduled for laparoscopic or robotic-assisted partial nephrectomy will be randomized to receive either AI-assisted surgical navigation (utilizing intraoperative 3D model overlay with automated registration) or conventional approaches. Comparative metrics will include ischemia time, margin positivity rate, and operative efficiency indices. Findings will inform iterative refinement of the system architecture based on clinical performance feedback.
- Conditions
- Renal Cell Cancer
- Being tested
- an AI-based real-time image-guided kidney model system
- Keywords
- partial nephrectomy, Articicial Intelligence, Intraoperative Real-Time Navigation
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an AI-based real-time image-guided kidney model systemProcedure or surgery
Use the AI-model to locate kidney and tumour, assisting surgeon with the operation
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgical Approaches | No intervention | perform conventional laparoscopic or robotic-assisted surgical approaches |
| AI model group | Experimental | Use the AI-model to locate kidney and tumour, assisting surgeon with the operation Receives: Procedure: an AI-based real-time image-guided kidney model system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Measured: Intraoperative
Secondary outcomes (1)
Operating Surgeon's Assessment
Scoring for Each Surgery(0-5) by navigation accuracy, image rendering smoothness
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 May 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shao Pengfei
- Sponsor type
- University, hospital or other
- Collaborators
- Southeast University, China
- Responsible party
- Sponsor-investigator, Shao Pengfei, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020169
- Sponsor's protocol ID
- 2025-SR-309
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 13 Jun 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Driven 3D Kidney Model for Real-Time Augmented Reality and Surgical Navigation in Minimally Invasive (Robotic/Laparoscopic) Partial Nephrectomy: A Prospective Validation Study
- ClinicalTrials.gov ID
- NCT07020169
- Acronym / sponsor ID
- 2025-SR-309
- Conditions
- Renal Cell Cancer
- Keywords
- partial nephrectomy, Articicial Intelligence, Intraoperative Real-Time Navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Shao PengfeiUniversity, hospital or other
- Collaborators
- Southeast University, China
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Jun 2025 (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 study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy:
- Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits?
Detailed description
This study aims to evaluate the feasibility of the AI-based real-time image-guided kidney model system in optimizing partial nephrectomy workflows. Patients scheduled for laparoscopic or robotic-assisted partial nephrectomy will be randomized to receive either AI-assisted surgical navigation (utilizing intraoperative 3D model overlay with automated registration) or conventional approaches. Comparative metrics will include ischemia time, margin positivity rate, and operative efficiency indices. Findings will inform iterative refinement of the system architecture based on clinical performance feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgical Approaches | No intervention | –perform conventional laparoscopic or robotic-assisted surgical approaches |
| AI model group | Experimental | Procedure: an AI-based real-time image-guided kidney model systemUse the AI-model to locate kidney and tumour, assisting surgeon with the operation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-80 years, regardless of gender
- Written informed consent obtained from the patient or legally authorized representative after full protocol disclosure
- Preoperative imaging (CT/MRI) confirming clinical stage T1a or select T1b renal tumors suitable for partial nephrectomy (R.E.N.A.L. nephrometry score ≤10)
- Localized renal tumors without lymph node/distant metastasis per NCCN Guidelines® (v2023)
- Elective minimally invasive partial nephrectomy (laparoscopic/robotic) after comprehensive surgical counseling
Key exclusion criteria (8 listed)
- Multifocal renal tumors (bilateral or unilateral)
- Prior systemic anticancer therapy (targeted agents/immunotherapy/chemotherapy) within 6 months
- Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)
- Intraoperative conversion to radical nephrectomy or open approach
- Postoperative adjuvant therapy during protocol-defined follow-up (12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an AI-based real-time image-guided kidney model systemUse the AI-model to locate kidney and tumour, assisting surgeon with the operation | Procedure or surgery | AI model group |
Primary outcome
Operative Time
Time frame: Intraoperative
1 secondary outcome
Operating Surgeon's Assessment
Time frame: immediately after the 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 13 Jun 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?
A study testing an AI-based real-time image-guided kidney model system in people with 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 8 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 13 Jun 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 Pengfei Shao, 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?
Operative Time (time frame: Intraoperative). 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 13 Jun 2025.