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

Launched by OBSTETRICS & GYNECOLOGY HOSPITAL OF FUDAN UNIVERSITY · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well an artificial intelligence (AI) tool can help doctors identify whether cancer has spread to the pelvic lymph nodes in women with cervical cancer. The researchers want to find out if this AI system, which combines different types of information (called multimodal fusion), is better than traditional imaging methods used by doctors. Participants in the study will have an MRI scan of their pelvis after being diagnosed with cervical cancer, and the results will help compare the AI's predictions with the doctors' assessments. Ultimately, the accuracy of both methods will be confirmed through surgery and pathology results.

To be eligible for this trial, participants need to be women aged 18 to 80 who have been diagnosed with invasive cervical cancer stages I to III and are planning to undergo surgery that includes removing lymph nodes. However, some women may be excluded from the study, such as those who are pregnant, have had recent chemotherapy or radiation, or have other serious health issues. The trial is not yet recruiting participants, so interested individuals will need to wait until it begins. This study aims to improve the way lymph node metastasis is diagnosed, which could lead to better treatment options for women with cervical cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • 1. patients with preoperative diagnosis of invasive cervical cancer stage I-III, with any type of pathology, and patients who underwent radical/modified radical cervical cancer surgery + pelvic lymph node dissection in our hospital or sub-center;
• • 2. Age ≥18 years and ≤80 years;
• • 3. patients who underwent preoperative pelvic MRI (plain/enhanced) imaging in our hospital or sub-centers.
• Exclusion criteria:
• • 1. patients during pregnancy or lactation, patients with abortion within 42 days;
• • 2. patients who are undergoing or have undergone preoperative neoadjuvant chemotherapy or radiotherapy for this cervical cancer;
• • 3. Patients with other malignant tumors within 5 years;
• • 4. Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes;
• • 5. patients whose preoperative pelvic MRI date is more than 1 month from the day of surgery;
• • 6. poor quality imaging images that are unrecognizable.