NCT06541288Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 1 Aug 2024
- Start date
- Aug 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Diseases
- Cervical cancer
- NCT number
- NCT06541288
What you commit to
- Study type: Interventional
- Planned participants: 230
- From Aug 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients whose preoperative pelvic MRI date is more than 1 month from the day of surgery;
Other illness
- 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;
Other
- patients during pregnancy or lactation, patients with abortion within 42 days;
- poor quality imaging images that are unrecognizable.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Obstetrics and Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.