NCT06541288

A Prospective Cohort Study Comparing AI Prediction Model With Imaging Assessment to Diagnose Lymph Node Metastasis in Cervical Cancer

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI Prediction Model	Pelvic MRI was performed after pathologic diagnosis clarified the diagnosis of cervical cancer. Further pelvic lymph node metastasis status was determined by artificial intelligence multimodal fusion prediction modeling
DIAGNOSTIC_TEST	Conventional Imageing Assessment	Pelvic MRI was performed after pathologic diagnosis clarified the diagnosis of cervical cancer.Further pelvic MRI images are read by a specialized imaging physician to determine pelvic lymph node status.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: China