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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05626127
Enrollment
60
Registered
2022-11-23
Start date
2022-11-20
Completion date
2024-12-01
Last updated
2022-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hilar Cholangiocarcinoma

Keywords

Hilar Cholangiocarcinoma, Lymph Node Metastasis, Radiomics, Machine-learning, Prognosis

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.

Interventions

OTHERNo interventions

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

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Lymph node metastasis statusBaselineThe value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.

Countries

China

Contacts

Primary ContactHonghua Zhang, PhD
zhanghh68@mail.sysu.edu.cn020-34078840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026