Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma

M

Ming Kuang

Status

Unknown

Conditions

Hepatocellular Carcinoma

Treatments

Diagnostic Test: Magnetic resonance image

Study type

Observational

Funder types

Other

Identifiers

NCT03198975
HCC10

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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;

Trial design

40 participants in 1 patient group

Preoperative imaging features
Description:
In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo preoperative Gd-EOB-DTPA enhanced magnetic resonance image.
Treatment:
Diagnostic Test: Magnetic resonance image

Trial contacts and locations

0

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Central trial contact

Jie Mei, MD; Zebin Chen, MD

Data sourced from clinicaltrials.gov

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