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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05257694
Other study ID # S2022-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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