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NCT Number: NCT07743749

An MRI-Based Study of Intelligent Pathological Subtyping and Grading of Renal Tumors

This retrospective + prospective, non-interventional study aims to develop and evaluate artificial intelligence methods for the detection, pathological subtyping, and histological grading of renal tumors using magnetic resonance imaging (MRI). Approximately 900 adult patients with available preoperative renal MRI examinations and postoperative pathological results will be included. The pathological findings will be used as the reference standard for model development and evaluation. In addition to MRI data, selected demographic, clinical, and laboratory information may be incorporated to improve model performance. The study will not change participants' diagnosis, treatment, or follow-up, and no additional examinations or interventions will be required. All study data will be de-identified before analysis. The ultimate goal is to develop an MRI-based intelligent diagnostic approach that may assist clinicians in the preoperative assessment and individualized management of patients with renal tumors.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, China

Location status: Recruiting

Location contact

xiongjun YE

CONTACT

[email protected]

010-87787170

About this study

Renal tumors include multiple benign and malignant pathological subtypes with substantial differences in biological behavior, treatment strategy, and prognosis. Surgical planning and clinical management are closely related to the pathological subtype and histological grade of the tumor. However, accurately determining these pathological characteristics before surgery using conventional MRI interpretation remains challenging.

This is a retrospective + prospective, observational, and non-interventional study. Adult patients with renal tumors will be identified from existing clinical records. Eligible patients will have available renal MRI examinations and corresponding pathological diagnoses, including pathological subtype and, when applicable, histological grade. Cases with unreadable MRI data or images of insufficient quality for analysis will be excluded.

Existing study data will include multisequence MRI examinations, such as T1-weighted imaging, T2-weighted imaging, diffusion-weighted imaging, apparent diffusion coefficient imaging, fat-suppressed imaging, and contrast-enhanced imaging, when available. Demographic information, relevant clinical history, laboratory results, and radiology report information may also be collected. Pathological findings will serve as the reference standard for model training and evaluation. All data will be de-identified before processing and analysis.

The study will develop artificial intelligence models for the following tasks:

  • Detection and localization of renal tumors on multisequence MRI.
  • Segmentation of renal tumors and extraction of quantitative imaging features.
  • Classification of common benign and malignant renal tumor subtypes.
  • Identification of rare pathological subtypes using small-sample or cross-modal learning methods.
  • Prediction of histological grade for malignant renal tumors.
  • Integration of MRI, demographic, clinical, and laboratory information to improve pathological subtyping and grading.

The dataset will be divided into model-development and validation datasets. Additional cases collected from different time periods or participating sources may be used for independent testing. Model performance will be evaluated by comparing artificial intelligence predictions with pathological diagnoses.

This study does not assign any treatment or diagnostic intervention. It will not affect participants' routine clinical care and will not require additional imaging examinations, blood collection, surgery, medication, or follow-up visits. The study is intended to develop an intelligent MRI-based diagnostic system that may support preoperative decision-making for patients with renal tumors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older.
  • Patients diagnosed with a renal tumor.
  • Availability of preoperative renal magnetic resonance imaging examinations.
  • Availability of a corresponding pathological diagnosis, including pathological subtype and, where applicable, histological grade.
  • Magnetic resonance images that can be successfully retrieved and are of - - sufficient quality for image analysis.

Exclusion criteria

  • Absence of renal magnetic resonance imaging data.
  • Absence of a corresponding pathological diagnosis or insufficient pathological subtype or grading information.
  • Magnetic resonance images that cannot be retrieved, opened, or read.
  • Poor image quality that precludes reliable image annotation or artificial intelligence analysis.

Treatment and study plan

MRI-Based Artificial Intelligence Analysis

Diagnostic Test

Existing preoperative multisequence renal MRI images, including T1-weighted imaging, T2-weighted imaging, diffusion-weighted imaging, apparent diffusion coefficient imaging, fat-suppressed imaging, and contrast-enhanced imaging when available, were retrospectively analyzed using artificial intelligence and deep learning methods. The models were developed to detect and segment renal tumors and to predict pathological subtype and histological grade. Postoperative pathological findings were used as the reference standard. No additional MRI examination or diagnostic procedure was performed for the study.

Primary outcomes

  1. Accuracy of MRI-Based Artificial Intelligence for Pathological Subtyping of Renal Tumors

    Time frame: At completion of model evaluation using retrospective data collected from January 2021 through July 2026 and prospective data collected through December 2026.

    The pathological subtype predicted by the MRI-based artificial intelligence model will be compared with the postoperative pathological diagnosis as the reference standard in the held-out test dataset. Accuracy will be calculated as the number of correctly classified renal tumors divided by the total number of renal tumors evaluated. Classification performance for individual pathological subtypes will also be summarized using sensitivity, specificity, and F1 score, where applicable.

  2. Accuracy of MRI-Based Artificial Intelligence for Histological Grading of Malignant Renal Tumors

    Time frame: At completion of model evaluation using retrospective data collected from January 2021 through July 2026 and prospective data collected through December 2026.

    The histological grade predicted by the MRI-based artificial intelligence model will be compared with the postoperative pathological grade as the reference standard. Histological grading will be assessed according to the four-tier World Health Organization/International Society of Urological Pathology grading system. Accuracy will be calculated as the number of malignant renal tumors with correctly predicted histological grade divided by the total number of malignant renal tumors evaluated.

Secondary outcomes

  1. Performance of the Artificial Intelligence Model for Renal Tumor Detection

    Time frame: At completion of model evaluation using retrospective data collected from January 2021 through July 2026 and prospective data collected through December 2026.

    The ability of the artificial intelligence model to detect and localize renal tumors on multisequence MRI will be evaluated by comparing model-generated tumor locations with expert manual annotations. Detection performance will be summarized using sensitivity and the proportion of correctly localized renal tumors.

  2. Accuracy of Artificial Intelligence-Based Renal Tumor Segmentation

    Time frame: At completion of model evaluation using retrospective data collected from January 2021 through July 2026 and prospective data collected through December 2026.

    Artificial intelligence-generated renal tumor segmentations will be compared with pixel-level manual annotations prepared under the supervision of experienced physicians. Segmentation agreement will be evaluated using the Dice similarity coefficient.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiongjun Ye

CONTACT

[email protected]

010-87787170 ext. 010-87787170

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
  • Chinese PLA General Hospital
  • Peking University People's Hospital
  • RenJi Hospital
  • Shanxi Province Cancer Hospital

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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