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Trial Title:
MRI-based Clinico-radiomics Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma
NCT ID:
NCT05626127
Condition:
Hilar Cholangiocarcinoma
Conditions: Official terms:
Neoplasm Metastasis
Cholangiocarcinoma
Lymphatic Metastasis
Klatskin Tumor
Conditions: Keywords:
Hilar Cholangiocarcinoma
Lymph Node Metastasis
Radiomics
Machine-learning
Prognosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
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.
Criteria for eligibility:
Study pop:
Patients who had resectable hilar cholangiocarcinoma and completed the upper abdomen MRI
examination before surgery.
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
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510220
Country:
China
Status:
Recruiting
Contact:
Last name:
Honghua Zhang, PhD
Phone:
020-34078840
Email:
zhanghh68@mail.sysu.edu.cn
Start date:
November 20, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626127
