MRI-based Clinico-radiomics Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2023

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.

Interventions

  • Other: No interventions
    • As this is a observational study, there are no interventions.

Arms, Groups and Cohorts

  • Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
    • The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the validation cohort.

Clinical Trial Outcome Measures

Primary Measures

  • Lymph node metastasis status
    • Time Frame: Baseline
    • The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.

Participating in This Clinical Trial

Inclusion Criteria

1. The patient must sign an informed consent form; 2. Age 18-75 years old, both male and female; 3. ECOG performance status score (PS score) 0-2; 4. Hilar cholangiocarcinoma with resectable tumor lesions; 5. Complete the upper abdomen MRI examination before treatment; Exclusion Criteria:

1. Accompanied with other primary malignant tumors; 2. Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies; 3. Incomplete imaging or medical history data.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chao Liu, PhD, Principal Investigator, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Overall Contact(s)
    • Honghua Zhang, PhD, 020-34078840, zhanghh68@mail.sysu.edu.cn

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