The AI Prognostic Assessment and Pathological Basis Research of Early HCC After Minimally Invasive Treatment

March 5, 2020 updated by: The First Affiliated Hospital of Dalian Medical University

The Artificial Intelligent Prognostic Assessment and Pathological Basis Research of Early Primary Hepatocellular Carcinoma After Minimally Invasive Treatment Based on Multimodal MRI and Clinical Big Data

The study evaluates artificial intelligence method based on multimodal magnetic resonance imaging (MRI) images and clinical data in preoperative prediction of prognosis in early hepatocellular carcinoma (HCC) patients treated with minimally invasive treatment. The correlation between prognosis-related MRI features and pathological features was studied through artificial intelligence method, so as to provide the interpretability of image features for predicting the prognosis of HCC patients treated with minimally invasive treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The prognosis prediction of early stage hepatocellular carcinoma (HCC) after minimally invasive treatment involves clinical decision of treatment and follow-up. Magnetic resonance imaging (MRI) has become the main approach for monitoring and following up of HCC, however it's difficult to predict HCC prognosis before surgery. We found the following limitations among previous researches: multimodal MRI using different sequences shows uncertain boundaries of HCC, which makes precise segmentation more difficult, and also leads to an additional workload for extracting high throughput radiomics features, which are limited in quantity and repeatability. Regarding to prognosis aspect, the MRI images, clinical data, and follow up information have not been fully exploited yet. In addition, the prognosis result obtained by radiomics workflow is difficult to be explained and applied to clinical application. Therefore, we conduct a study to solve the problems mentioned above: (1) To explore an effective deep learning neural network method and a pre-training model for improving tumor segmentation accuracy. (2) To establish a method for extracting high-throughput multi-dimensional and multimodal MRI radiomics features related to HCC prognosis. (3) To explore a correlation between "multimodal MRI based pathological features of early stage HCC" and the results of "multimodal MRI based prognosis depth network of early stage HCC after minimally invasive treatment". Based on above approaches, we aim to establish "multimodal MRI based prognosis model of early stage HCC after minimally invasive treatment" in different clinical application scenarios guiding to clinical decision-making. Moreover, we also aim to explore the correlation between MRI radiomics features and pathology, which provides theoretical foundations for the MRI radiomics based pathological researches.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • The First Affiliated Hospital of Dalian Medical University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients underwent MRI examination of the abdomen in our hospital.

Description

Inclusion Criteria:

  • Hepatocellular carcinoma patients received minimally invasive treatment (transcatheter arterial chemoembolization, radiofrequency ablation, or combined) or hepatectomy;
  • Patients received MRI examination within 1 month before treatment;
  • Complete post-treatment prognosis information.

Exclusion Criteria:

  • local or systemic treatment before MR examination;
  • Incomplete clinical and pathological data;
  • Heavy image artifacts.

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
Recurrence
All hepatocellular carcinoma (HCC) patients have been regularly monitored for recurrence via contrast CT or contrast-enhanced MRI after minimally invasive treatment or hepatectomy. The recurrence status included new intrahepatic lesions and/or extrahepatic metastasis.
Procedure: Minimally invasive treatment
All hepatocellular carcinoma (HCC) patients received minimally invasive treatment, including transcatheter arterial chemoembolization (TACE), radiofrequency ablation (RFA) or combined.
Procedure: Hepatectomy
All hepatocellular carcinoma (HCC) patients received hepatectomy.
Non-recurrence
All hepatocellular carcinoma (HCC) patients have been regularly monitored for recurrence via contrast CT or contrast-enhanced MRI after minimally invasive treatment or hepatectomy. The recurrence status included new intrahepatic lesions and/or extrahepatic metastasis.
Procedure: Minimally invasive treatment
All hepatocellular carcinoma (HCC) patients received minimally invasive treatment, including transcatheter arterial chemoembolization (TACE), radiofrequency ablation (RFA) or combined.
Procedure: Hepatectomy
All hepatocellular carcinoma (HCC) patients received hepatectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three-month recurrence
Time Frame: Three months
All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least three months.
Three months
Six-month recurrence
Time Frame: Six months
All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least six months.
Six months
One-year recurrence
Time Frame: One year
All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least one year.
One year
Two-year recurrence
Time Frame: Two years
All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least two years.
Two years
Three-year recurrence
Time Frame: Three years
All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least three years.
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Three months, six months, one year, two years, and three years.
The time between the tumor progression and initial treatment was recorded.
Three months, six months, one year, two years, and three years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Investigators

  • Study Chair: Ying Zhao, MD, The First Affiliated Hospital of Dalian Medical University

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

Helpful Links

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)

April 1, 2007

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJ-KS-KY-2019-167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Partial de-identified individual participant data for primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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