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

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

Sponsors

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

Source 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.

Overall Status Recruiting
Start Date 2022-11-20
Completion Date 2024-12-01
Primary Completion Date 2023-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Lymph node metastasis status Baseline
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: No interventions

Description: As this is a observational study, there are no interventions.

Arm Group Label: Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Chao Liu, PhD Principal Investigator Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Overall Contact

Last Name: Honghua Zhang, PhD

Phone: 020-34078840

Email: [email protected]

Location
Facility: Status: Contact: Sun Yat-sen Memorial Hospital, Sun Yat-sen University Honghua Zhang, PhD 020-34078840 [email protected]
Location Countries

China

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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Clinical Trials on Hilar Cholangiocarcinoma

Clinical Trials on No interventions