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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedStudy Start
First participant enrolled
November 20, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 23, 2022
November 1, 2022
1 year
November 16, 2022
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lymph node metastasis status
The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.
Baseline
Study Arms (1)
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.
Interventions
As this is a observational study, there are no interventions.
Eligibility Criteria
Patients who had resectable hilar cholangiocarcinoma and completed the upper abdomen MRI examination before surgery.
You may qualify if:
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Hilar cholangiocarcinoma with resectable tumor lesions;
- Complete the upper abdomen MRI examination before treatment;
You may not qualify if:
- Accompanied with other primary malignant tumors;
- Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
- Incomplete imaging or medical history data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510220, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chao Liu, PhD
Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 23, 2022
Study Start
November 20, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
November 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share