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NCT07912853

Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death globally. Surgical resection is the mainstay of curative-intent treatment, but the 5-year postoperative recurrence rate can be as high as 70%. Tumor heterogeneity is a major driver of recurrence and continues to complicate individualized treatment decision-making. For example, extended resection may improve radicality but risks hepatic decompensation, whereas limited resection preserves liver function but may leave microscopic invasive foci. Therefore, accurate preoperative evaluation of tumor invasiveness is critical to achieving a delicate balance between radicality and safety, and to improving long-term survival. Multiparametric MRI is the most comprehensive noninvasive modality for assessing HCC invasiveness. However, most existing models are primarily data-driven and lack histopathological or molecular validation of their underlying mechanisms. They also lack precise spatial localization, limiting their direct application to surgical planning. A bottleneck is the lack of precise imaging-pathology correspondence, resulting from mismatches between macroscopic imaging and microscopic histology in both spatial registration and sampling adequacy. This gap also makes it difficult to establish a coherent link between imaging phenotypes and postoperative recurrence risk. Therefore, this prospective observational cohort study aims to construct a multidimensional Imaging, Molecular, Pathological, And Clinical Outcome (IMPACT) database in patients undergoing curative resection for single BCLC 0/A HCC. The study has three major objectives: 1. Cross-scale imaging-pathology-molecular correlations: to spatially correlate multiparametric MRI and photon-counting CT (PCCT) imaging features with pathologic and molecular features, as well as with prognosis, thereby elucidating the biological mechanisms underlying imaging markers and phenotypes. 2. Prospective validation of prognostic models: to validate the predictive performance of the MERP, SPAN, and related models for recurrence-free survival (RFS), overall survival (OS), and other endpoints; 3. Imaging-guided individualized surveillance: to explore the role of abbreviated MRI (AMRI)-based surveillance in the postoperative follow-up of patients at high risk of recurrence. By integrating imaging phenotypes, pathological immune microenvironment, genomic alterations, and clinical outcomes into a four-dimensional radiogenomic framework, this database will support a shift towards the "imaging-as-virtual-biopsy" paradigm, inform individualized surgical planning, perioperative treatment, and postoperative surveillance.

Official title: Integration of Multidimensional Imaging, Molecular, Pathological, And Clinical Outcome Data in Hepatocellular Carcinoma: Collection of the Prospective IMPACT Cohort.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

380

Start Date

2027-01-01

Completion Date

2029-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

PROCEDURE

Resection

Hepatocellular carcinoma that is amenable to R0 surgical resection with curative intent in the opinion of the multidisciplinary tumor board involved in the care of the participant.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China