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

Obstetrics & Gynecology Hospital of Fudan University

Status: Not yet enrolling

Conditions: Uterine Cervical Neoplasms

Treatments: Diagnostic Test: AI Prediction Model; Diagnostic Test: Conventional Imageing Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06541288

FUOBGY-2024-64

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

AI Prediction Model

Experimental group

Treatment:

Diagnostic Test: AI Prediction Model

Conventional Imageing Assessment

Active Comparator group

Treatment:

Diagnostic Test: Conventional Imageing Assessment