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The Application Value of Artificial Intelligence in MRI Precision Diagnosis and Treatment of Bladder Cancer

Prospective Multi-center Clinical Study on the Application Value of Artificial Intelligence in MRI Precision Diagnosis and Treatment of Bladder Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05096533
Enrollment
150
Registered
2021-10-27
Start date
2021-01-01
Completion date
2023-01-01
Last updated
2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder Cancer, MRI, Artificial intelligence

Brief summary

This study was a prospective, multicenter observational clinical study, A total of 150 patients with bladder malignant tumor who was admitted to the urology department of each center for treatment and underwent electric resection or radical cystectomy were planned to be enrolled. In order to analyze the sensitivity、specificity and accuracy of artificial intelligence in predicting postoperative pathological staging, Patients who entered the group were followed up for 3 years, then, we analyzed the correlation between artificial intelligence prediction results and patient OS PFS RFS. It was preliminarily verified that the results of the artificial intelligence model have the potential to predict the prognosis of patients with bladder cancer.

Detailed description

Preliminary research: This research is multi-disciplinary joint research by combining artificial intelligence with magnetic resonance, it can make the preoperative determination of bladder cancer stage more accurate and guides the clinician worker's treatment plan. At present, It has been constructed that an artificial intelligence model based on preoperative magnetic resonance images to predict staging and patient prognosis. We built a staging prediction model through deep learning artificial intelligence network, and collected magnetic resonance image data and related postoperative pathological data of patients, afterwards, We followed 576 patients on the basis of staging model construction. By obtaining OS, PFS, and RFS of patients, a part was randomly selected as a training set for training the deep learning network model. The other part is used as a test set to verify its accuracy. This study was a prospective, multicenter observational clinical study, A total of 150 patients with bladder malignant tumor who was admitted to the urology department of each center for treatment and underwent electric resection or radical cystectomy were planned to be enrolled. In order to analyze the sensitivity、specificity and accuracy of artificial intelligence in predicting postoperative pathological staging, Patients who entered the group were followed up for 3 years, then, we analyzed the correlation between artificial intelligence prediction results and patient OS PFS RFS. It was preliminarily verified that the results of the artificial intelligence model have the potential to predict the prognosis of patients with bladder cancer.

Interventions

None listed

Sponsors

Nanjing University of Aeronautics and Astronautics
CollaboratorUNKNOWN
The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Preoperative examination prompts the patient to be bladder cancer; 2. There is no limit on the gender; 3. The age of 18 years old or more; 4. Can provide preoperative MRI images; 5. Agree to provide personal basic clinical information and pathological and imaging data for scientific research, and sign informed consent; 6. Agree to provide monitoring results during follow-up monitoring for recurrence.

Exclusion criteria

1. Patient was unable to provide preoperative MRI images, including MRI images after neoadjuvant therapy and before surgery; 2. Patients with incomplete pathological information of samples were unable to provide accurate staging and grading information; 3. Patients cannot be operated on due to their own reasons: severe heart failure, acute myocardial infarction, severe heart and lung diseases, etc., they cannot tolerate normal surgical treatment; 4. Patients who had recently undergone surgery (e.g., TURBT) prior to MRI examination; 5. The researcher thinks there are any conditions that may impair the subject or cause the subject to fail to meet or perform study requirements; 6. Patients unable to provide written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
To explore the application value of artificial intelligence in the precise diagnosis and treatment of bladder tumor, and to improve the accuracy of MRI diagnosis of bladder cancer stage and grade through artificial intelligence.1 year2、Through Concordance analysis of artificial intelligence diagnosis assay results with gold standard results of surgery, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of artificial intelligence diagnosis before the operation.

Secondary

MeasureTime frameDescription
Overall survival3 years after surgeryThe correlation between artificial intelligence model and OS in bladder cancer patients was analyzed to preliminarily verify the potential ability of artificial intelligence model results in predicting the prognosis of bladder cancer patients.

Other

MeasureTime frameDescription
recurrence-free survival3 years after surgeryThe correlation between artificial intelligence model and RFS in bladder cancer patients was analyzed to preliminarily verify the potential ability of artificial intelligence model results in predicting the prognosis of bladder cancer patients.
progression-free survival3 years after surgeryThe correlation between artificial intelligence model and PFS in bladder cancer patients was analyzed to preliminarily verify the potential ability of artificial intelligence model results in predicting the prognosis of bladder cancer patients.

Countries

China

Contacts

Primary ContactLingkai Cai
lingkaicai1996@163.com+86 15206213500
Backup ContactQiang Lv, MD,PHD
doctorlvqiang@njmu.edu.cn+86 13505196501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026