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

Hilar Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626127
• Other study ID #: SYSKY-2022-267-01
• Status: Recruiting
• Start date: November 20, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Honghua Zhang, PhD
• Phone: 020-34078840
• Email: zhanghh68[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hilar Cholangiocarcinoma
• Klatskin Tumor
• Lymphatic Metastasis
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymph node metastasis status	The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.	Baseline