- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198975
Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma
June 22, 2017 updated by: Ming Kuang
Development of a Machine Learning-based Model for Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zebin Chen, MD
- Phone Number: +86 13316284086
- Email: chenzebin_2008@126.com
Study Contact Backup
- Name: Jie Mei, MD
- Phone Number: +86 15817089979
- Email: mmjj0926@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Chen Zebin
- Phone Number: +8615017581009
- Email: chenzebin_2008@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Between June 2017 and July 2017,all patients who will undergo curative resection (R0 resection) at the First Affiliated Hospital of Sun YatSen University in Guangzhou, China, for HCC based on the modified WHO classification of tumors of the digestive system, are considered for inclusion.
By the eligibility criteria stated below, MVI presentative rate is 30-42% in chinese HCC population as reported, we retrospectively collected about 80 patients for training and an estimated 40 patients will be needed for validation set of this study.
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of microvascular invasion
Time Frame: Through patient enrollment completion ,an average of 2 years
|
Postoperative histologically confirmed microvascular invasion
|
Through patient enrollment completion ,an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ming Kuang, PhD, Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Nat Commun. 2014;5:4644. Cavalho, Sara [corrected to Carvalho, Sara].
- 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.
- 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. Erratum In: J Clin Oncol. 2016 Jul 10;34(20):2436.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2017
Primary Completion (Anticipated)
July 31, 2017
Study Completion (Anticipated)
July 31, 2017
Study Registration Dates
First Submitted
June 22, 2017
First Submitted That Met QC Criteria
June 22, 2017
First Posted (Actual)
June 26, 2017
Study Record Updates
Last Update Posted (Actual)
June 26, 2017
Last Update Submitted That Met QC Criteria
June 22, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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