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Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research

C

Chinese PLA General Hospital (301 Hospital)

Status

Enrolling

Conditions

Hepatocellular Carcinoma Stage III

Treatments

Procedure: Hepatectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06559761
S2024-423

Details and patient eligibility

About

Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

Ultrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

By analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.
  • The initial treatment is curative-intent hepatectomy.
  • There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.
  • Age 18-80 years old.

Exclusion criteria

· Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.

Trial design

500 participants in 4 patient groups

TYPE I
Description:
Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope
Treatment:
Procedure: Hepatectomy
TYPE II
Description:
Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points
Treatment:
Procedure: Hepatectomy
TYPE III
Description:
Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules
Treatment:
Procedure: Hepatectomy
TYPE IV
Description:
Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points
Treatment:
Procedure: Hepatectomy

Trial contacts and locations

1

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Central trial contact

Chuan Pang

Data sourced from clinicaltrials.gov

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