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Clinical Trials/NCT06541288
NCT06541288
Not yet recruiting
Not Applicable

A Prospective Cohort Study Comparing Artificial Intelligence Multimodal Fusion Prediction Models With Conventional Imaging Assessment for the Diagnosis of Pelvic Lymph Node Metastasis in Cervical Cancer

Obstetrics & Gynecology Hospital of Fudan University1 site in 1 country230 target enrollmentAugust 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Cervical Neoplasms
Sponsor
Obstetrics & Gynecology Hospital of Fudan University
Enrollment
230
Locations
1
Primary Endpoint
Accuracy in determining pelvic lymph node metastasis
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this prospective cohort study is to learn whether artificial intelligence multimodal fusion prediction models are effective in diagnosing pelvic lymph node metastasis in cervical cancer. The main question it aims to answer is: can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.

Registry
clinicaltrials.gov
Start Date
August 2024
End Date
December 2027
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
Obstetrics & Gynecology Hospital of Fudan University
Responsible Party
Principal Investigator
Principal Investigator

Xin Wu

Deputy Chief of Gynecologic Oncology

Obstetrics & Gynecology Hospital of Fudan University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Accuracy in determining pelvic lymph node metastasis

Time Frame: The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.

After the subjects underwent surgical treatment, surgical pathology served as the gold standard for evaluating the accuracy of the AI predictive model in comparison to traditional imaging diagnosis. In the statistical analysis phase, sensitivity and specificity were utilized as the primary indicators to assess the accuracy of both diagnostic modalities.

Study Sites (1)

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