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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05626127
Collaborator
(none)
60
1
24.4
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No interventions

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of a MRI-based Clinico-radiomics Model in Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma Patients: a Prospective Diagnostic Study
Anticipated Study Start Date :
Nov 20, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Lymph node metastasis status [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510220

Sponsors and Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Chao Liu, PhD, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05626127
Other Study ID Numbers:
  • SYSKY-2022-267-01
First Posted:
Nov 23, 2022
Last Update Posted:
Nov 23, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2022