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

NCT ID: NCT05626127

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-20

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Hilar Cholangiocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions

Intervention Type OTHER

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

Interventions

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No interventions

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chao Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Locations

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Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Honghua Zhang, PhD

Role: CONTACT

020-34078840

Facility Contacts

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Honghua Zhang, PhD

Role: primary

020-34078840

Other Identifiers

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SYSKY-2022-267-01

Identifier Type: -

Identifier Source: org_study_id

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