Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma

NCT ID: NCT03198975

Last Updated: 2017-06-26

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-23

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preoperative imaging features

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.

Magnetic resonance image

Intervention Type DIAGNOSTIC_TEST

Histologically-diagnosed primary HCC after curative hepatectomy. The magnetic resonance image will be imported into the software ,and the radiomic textural features will be automatically extracted by the Analysis-Kit software.The high-throughput extracted features will be then selected and a prediction model will be developed in the training set in which patients were collected from a retrospective study. In this project, an independent validation set will be collected and used to validate the prediction accuracy of the model.

Interventions

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Magnetic resonance image

Histologically-diagnosed primary HCC after curative hepatectomy. The magnetic resonance image will be imported into the software ,and the radiomic textural features will be automatically extracted by the Analysis-Kit software.The high-throughput extracted features will be then selected and a prediction model will be developed in the training set in which patients were collected from a retrospective study. In this project, an independent validation set will be collected and used to validate the prediction accuracy of the model.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ming Kuang

OTHER

Sponsor Role lead

Responsible Party

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Ming Kuang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ming Kuang, PhD

Role: STUDY_DIRECTOR

Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Locations

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zebin Chen, MD

Role: CONTACT

+86 13316284086

Jie Mei, MD

Role: CONTACT

+86 15817089979

Facility Contacts

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Chen Zebin

Role: primary

+8615017581009

References

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Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006.

Reference Type RESULT
PMID: 24892406 (View on PubMed)

Zhang YD, Wang Q, Wu CJ, Wang XN, Zhang J, Liu H, Liu XS, Shi HB. The histogram analysis of diffusion-weighted intravoxel incoherent motion (IVIM) imaging for differentiating the gleason grade of prostate cancer. Eur Radiol. 2015 Apr;25(4):994-1004. doi: 10.1007/s00330-014-3511-4. Epub 2014 Nov 28.

Reference Type RESULT
PMID: 25430007 (View on PubMed)

Woo S, Lee JM, Yoon JH, Joo I, Han JK, Choi BI. Intravoxel incoherent motion diffusion-weighted MR imaging of hepatocellular carcinoma: correlation with enhancement degree and histologic grade. Radiology. 2014 Mar;270(3):758-67. doi: 10.1148/radiol.13130444. Epub 2013 Oct 30.

Reference Type RESULT
PMID: 24475811 (View on PubMed)

Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.2015.65.9128. Epub 2016 May 2.

Reference Type RESULT
PMID: 27138577 (View on PubMed)

Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.

Reference Type RESULT
PMID: 26579733 (View on PubMed)

Other Identifiers

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HCC10

Identifier Type: -

Identifier Source: org_study_id

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