Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning

Hepatocellular Carcinoma Clinical Trial

Official title:

A Deep Learning Model Based on Contrast-enhanced Ultrasound to Aid Clinical Decisions and Predict Biological Biomarker and Prognosis of Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257694
• Other study ID #: S2022-002
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Chinese PLA General Hospital
• Contact: Ping Liang, Dr.
• Phone: +86 10 66939530
• Email: liangping301[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions

Description:

Collecting CEUS and clinical data of HCC from different institutions retrospectively. Developing a deep learning model based on CEUS to predict the prognosis of HCC. Developing a deep learning model based on CEUS to choose a better operation (ablation or surgery) of HCC patients. Then, validating the deep learning model in the prospective data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation
• without macro-vascular invasion
• Child-Pugh A/B grade
• HCC is proved by pathological examination or two enhanced imaging
• CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation
• Invasive biomarker or prognosis of HCC available
• CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase)

Exclusion Criteria:

• postop follow-up loss or expired less than 3 months
• patients with co-malignancy
• poor images quality for analyzing

Related Conditions & MeSH terms

• Ablation
• Carcinoma
• Carcinoma, Hepatocellular
• Contrast-enhanced Ultrasound
• Hepatocellular Carcinoma
• Prognosis
• Surgery

Intervention

Procedure:
• Surgery
hepatectomy
• Ablation (Microwave ablation or Radiofrequency ablation)
image-guided ablation

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ping Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival (RFS)	Recurrence-free survival is defined as the time elapsed between a predefined point in time (the date of diagnosis, randomization or the intervention) and any recurrence (local, regional, or distant) or death due to any cause (death is an event).	Immediately after the surgery or ablation
Secondary	Recurrence	Recurrence included local tumor progression, regional recurrence, or distant recurrence.	Immediately after the surgery or ablation