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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

This retrospective + prospective, hospital-based study includes adult patients with renal tumors who underwent preoperative renal MRI as part of routine clinical care and had corresponding pathological diagnoses. Eligible cases include benign and malignant renal tumor subtypes. Existing de-identified MRI, pathological, demographic, clinical, and laboratory data are collected for artificial intelligence model development and evaluation. No healthy volunteers are included, and no additional examinations, treatments, or study-specific follow-up are performed.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Patients With Renal Tumors1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
At completion of model evaluation using retrospective data collected from January 2021 through July 2026 and prospective data collected through December 2026.
2

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

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.

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

Secondary outcomes

1

Performance of the Artificial Intelligence Model for Renal Tumor Detection

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.

Time frame
At completion of model evaluation using retrospective data collected from January 2021 through July 2026 and prospective data collected through December 2026.
2

Accuracy of Artificial Intelligence-Based Renal Tumor Segmentation

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking University People's Hospital

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

RenJi Hospital

Collaborator

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Collaborator