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

Recruiting

• Conditions: Hilar Cholangiocarcinoma
• Interventions: Other: No interventions

• Registration Number: NCT05626127
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Study Start: 2022-11-20
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University	No interventions	The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the validation cohort.

Primary Outcome Measures

Name	Time	Method
Lymph node metastasis status	Baseline	The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China