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Clinical Trials/NCT05626127
NCT05626127
Recruiting
Not Applicable

Evaluation of a MRI-based Clinico-radiomics Model in Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma Patients: a Prospective Diagnostic Study

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country60 target enrollmentNovember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hilar Cholangiocarcinoma
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
60
Locations
1
Primary Endpoint
Lymph node metastasis status
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This is a prospective, observational diagnostic study aiming to assess multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma.

Detailed Description

A preoperative tool capable of predicting lymph node metastasis status in hilar cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a machine-learning algorithms of multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma. This study will investigate the relationship between radiomic depth information and tumor biological characteristics. The study includes the construction of capable MRI-based clinico-radiomics prediction model and the validation of the prediction model.

Registry
clinicaltrials.gov
Start Date
November 20, 2022
End Date
December 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • The patient must sign an informed consent form;
  • Age 18-75 years old, both male and female;
  • ECOG performance status score (PS score) 0-2;
  • Hilar cholangiocarcinoma with resectable tumor lesions;
  • Complete the upper abdomen MRI examination before treatment;

Exclusion Criteria

  • Accompanied with other primary malignant tumors;
  • Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
  • Incomplete imaging or medical history data.

Outcomes

Primary Outcomes

Lymph node metastasis status

Time Frame: Baseline

The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.

Study Sites (1)

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