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

NCT04299919 | Unknown DMC

• 1 other identifier: PJ-KS-KY-2019-167
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Precision medicine information processing; Lesion recognition; Feature extraction; Deep learning; Diagnosis model

Outcome Measures

Primary Outcomes (5)

• Three-month recurrence

  All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least three months.

  Three months

• Six-month recurrence

  All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least six months.

  Six months

• One-year recurrence

  All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least one year.

  One year

• Two-year recurrence

  All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least two years.

  Two years

• Three-year recurrence

  All HCC patients have been regularly monitored for recurrence via contrast CT or MRI for at least three years.

  Three years

Secondary Outcomes (1)

• Progression-free survival

  Three months, six months, one year, two years, and three years.

Study Arms (2)

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; Procedure: 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; Procedure: Hepatectomy

Interventions

Minimally invasive treatment PROCEDURE

All hepatocellular carcinoma (HCC) patients received minimally invasive treatment, including transcatheter arterial chemoembolization (TACE), radiofrequency ablation (RFA) or combined.

Non-recurrence; Recurrence

Hepatectomy PROCEDURE

All hepatocellular carcinoma (HCC) patients received hepatectomy.

Non-recurrence; Recurrence

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent MRI examination of the abdomen in our hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

Related Publications (21)

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• Ye JZ, Chen JZ, Li ZH, Bai T, Chen J, Zhu SL, Li LQ, Wu FX. Efficacy of postoperative adjuvant transcatheter arterial chemoembolization in hepatocellular carcinoma patients with microvascular invasion. World J Gastroenterol. 2017 Nov 7;23(41):7415-7424. doi: 10.3748/wjg.v23.i41.7415.

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• Li S, Zhang L, Huang ZM, Wu PH. Transcatheter arterial chemoembolization combined with CT-guided percutaneous thermal ablation versus hepatectomy in the treatment of hepatocellular carcinoma. Chin J Cancer. 2015 Jun 10;34(6):254-63. doi: 10.1186/s40880-015-0023-9.

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• Yasaka K, Akai H, Abe O, Kiryu S. Deep Learning with Convolutional Neural Network for Differentiation of Liver Masses at Dynamic Contrast-enhanced CT: A Preliminary Study. Radiology. 2018 Mar;286(3):887-896. doi: 10.1148/radiol.2017170706. Epub 2017 Oct 23.

  PMID: 29059036 BACKGROUND

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• Song W, Yu X, Guo D, Liu H, Tang Z, Liu X, Zhou J, Zhang H, Liu Y, Liu X. MRI-Based Radiomics: Associations With the Recurrence-Free Survival of Patients With Hepatocellular Carcinoma Treated With Conventional Transcatheter Arterial Chemoembolization. J Magn Reson Imaging. 2020 Aug;52(2):461-473. doi: 10.1002/jmri.26977. Epub 2019 Nov 1.

  PMID: 31675174 BACKGROUND

• Hui TCH, Chuah TK, Low HM, Tan CH. Predicting early recurrence of hepatocellular carcinoma with texture analysis of preoperative MRI: a radiomics study. Clin Radiol. 2018 Dec;73(12):1056.e11-1056.e16. doi: 10.1016/j.crad.2018.07.109. Epub 2018 Sep 10.

  PMID: 30213434 BACKGROUND

• Wu M, Tan H, Gao F, Hai J, Ning P, Chen J, Zhu S, Wang M, Dou S, Shi D. Predicting the grade of hepatocellular carcinoma based on non-contrast-enhanced MRI radiomics signature. Eur Radiol. 2019 Jun;29(6):2802-2811. doi: 10.1007/s00330-018-5787-2. Epub 2018 Nov 7.

  PMID: 30406313 BACKGROUND

• Li Z, Mao Y, Huang W, Li H, Zhu J, Li W, Li B. Texture-based classification of different single liver lesion based on SPAIR T2W MRI images. BMC Med Imaging. 2017 Jul 13;17(1):42. doi: 10.1186/s12880-017-0212-x.

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• Kim J, Choi SJ, Lee SH, Lee HY, Park H. Predicting Survival Using Pretreatment CT for Patients With Hepatocellular Carcinoma Treated With Transarterial Chemoembolization: Comparison of Models Using Radiomics. AJR Am J Roentgenol. 2018 Nov;211(5):1026-1034. doi: 10.2214/AJR.18.19507. Epub 2018 Sep 21.

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• Zhou Y, He L, Huang Y, Chen S, Wu P, Ye W, Liu Z, Liang C. CT-based radiomics signature: a potential biomarker for preoperative prediction of early recurrence in hepatocellular carcinoma. Abdom Radiol (NY). 2017 Jun;42(6):1695-1704. doi: 10.1007/s00261-017-1072-0.

  PMID: 28180924 BACKGROUND

• Huang YL, Chen JH, Shen WC. Diagnosis of hepatic tumors with texture analysis in nonenhanced computed tomography images. Acad Radiol. 2006 Jun;13(6):713-20. doi: 10.1016/j.acra.2005.07.014.

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• Tang H, Bai HX, Su C, Lee AM, Yang L. The effect of cirrhosis on radiogenomic biomarker's ability to predict microvascular invasion and outcome in hepatocellular carcinoma. Hepatology. 2016 Aug;64(2):691-2. doi: 10.1002/hep.28620. Epub 2016 May 31. No abstract available.

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• Wu LF, Rao SX, Xu PJ, Yang L, Chen CZ, Liu H, Huang JF, Fu CX, Halim A, Zeng MS. Pre-TACE kurtosis of ADCtotal derived from histogram analysis for diffusion-weighted imaging is the best independent predictor of prognosis in hepatocellular carcinoma. Eur Radiol. 2019 Jan;29(1):213-223. doi: 10.1007/s00330-018-5482-3. Epub 2018 Jun 19.

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• Choi JW, Chung JW, Lee DH, Kim HC, Hur S, Lee M, Jae HJ. Portal hypertension is associated with poor outcome of transarterial chemoembolization in patients with hepatocellular carcinoma. Eur Radiol. 2018 May;28(5):2184-2193. doi: 10.1007/s00330-017-5145-9. Epub 2017 Dec 7.

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Related Links

• Transcatheter arterial chemoembolization.
• Efficacy of postoperative in hepatocellular carcinoma patients with microvascular invasion.
• Transcatheter arterial chemoembolization.
• The prognostic values.
• Portal hypertension.
• Deep Learning.
• The segmentation of the portal vein.
• MRI-Based Radiomics.
• A radiomics study.
• Predicting the grade of hepatocellular carcinoma.
• Texture-based classification of different single liver lesion.
• Comparison of Models Using Radiomics.
• CT-based radiomics signature.
• Diagnosis of hepatic tumors with texture analysis.
• The predicting microvascular invasion and outcome in hepatocellular carcinoma.
• The best independent predictor of prognosis in hepatocellular carcinoma.
• Evaluation of the efficacy of hepatocellular carcinoma.
• The therapeutic effect of transarterial chemoembolization for hepatocellular carcinoma.
• The survival prognosis in patients with hepatocellular carcinoma treated by conventional TACE.
• Transcatheter arterial chemoembolisation.
• Portal hypertension is associated with poor outcome of transarterial chemoembolization in patients with hepatocellular carcinoma.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ying Zhao, MD

  The First Affiliated Hospital of Dalian Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: April 1, 2007
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

Locations

CN (1)