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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Age ≥18 years and ≤80 years;

patients who underwent preoperative pelvic MRI (plain/enhanced) imaging in our hospital or sub-centers.

Disqualifiers

patients during pregnancy or lactation, patients with abortion within 42 days;

patients who are undergoing or have undergone preoperative neoadjuvant chemotherapy or radiotherapy for this cervical cancer;

Patients with other malignant tumors within 5 years;

Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes;

Trial design

Design model

Factorial

Treatments tested in this trial

  • AI Prediction Model

    Diagnostic test

    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

  • Conventional Imageing Assessment

    Diagnostic test

    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.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: AI Prediction ModelExperimental treatment 1 intervention
Group B: Conventional Imageing AssessmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy in determining pelvic lymph node metastasis

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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