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Clinical Trials/NCT03198975
NCT03198975UnknownNot Applicable

Development of a Machine Learning-based Model for Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma

Ming Kuang1 site in 1 country40 target enrollmentStarted: June 23, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Presence of microvascular invasion

Study Overview

Brief Summary

Microvascular invasion (MVI) has been well demonstrated as an unfavorable prognostic factor for hepatocellular carcinoma (HCC), and patients with MVI have a high risk of tumor recurrence after curative hepatectomy. Currently, the diagnosis of MVI is determined on the postoperative histologic examination, which greatly limits its influence on preoperative decision making. Therefore, we constructed this prospective study to develop a machine learning-based model for preoperative prediction of MVI by extracting high-dimensional magnetic resonance (MR) image features.

Detailed Description

Histologically-diagnosed primary HCC after curative hepatectomy. The magnetic resonance image will be imported into the imaging management software (GE healthcare Analysis-Kit software),and the tumor lesions will manually delineated by two independent radiologists and then reconstruct into three-dimensional images for feature extraction. The radiomic textural features including grayscale histogram, transform matrix, wavelet transform and filter transformation are automatically extracted by the Analysis-Kit software.The high-throughput extracted features will be then selected by the univariate analysis, and a prediction model will be developed based on machine learning algorithm in a training set in which patients were collected from a retrospective study. And in the present study, an independent validation set will be collected and used to validate the prediction accuracy of the model.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Asian patients aged 18~80 years old;
  • •HCC without macroscopic vascular invasion according to imaging findings;
  • •Child Pugh A-B stage;
  • •Receipt of preoperative Gd-EOB-DTPA enhanced MR imaging of the abdomen within one month before surgery;
  • •Histologically-diagnosed primary HCC after curative hepatectomy;

Exclusion Criteria

  • •Combined hepatocellular-cholangiocarcinoma;
  • •With extra-hepatic metastasis or macrovascular invasion;
  • •With incomplete clinical and imaging data;
  • •Non-radical resection;

Outcomes

Primary Outcomes

Presence of microvascular invasion

Time Frame: Through patient enrollment completion ,an average of 2 years

Postoperative histologically confirmed microvascular invasion

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ming Kuang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ming Kuang

Professor

Sun Yat-sen University

Study Sites (1)

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