Multimodalomics-based Construction of Spatiotemporal Characteristics of Dynamic Liver Cancer Microenvironment to Characterize the Clinical Application of Immune Mechanisms in Liver Cancer

NCT07838415 | Recruiting

• 1 other identifier: TJ-IRB202412046
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore whether adding an additional MRI sequence to routine liver scans can better characterize the immune microenvironment of liver cancer. We plan to prospectively enroll patients diagnosed with or suspected of having liver cancer who undergo routine MRI examinations. In addition to the standard MRI protocol, participants will receive one extra MRI sequence. We will analyze the imaging features from this additional sequence and combine them with clinical data to construct a multi-omics model. The goal is to identify imaging biomarkers that can reflect the dynamic changes of the tumor microenvironment, which may help improve the diagnosis and clinical management of liver cancer.

Conditions

Hepatocellular Carcinoma (HCC); Treatment Response

Outcome Measures

Primary Outcomes (1)

• The primary outcomes of this study were PFS

  PFS was calculated from the time of receiving treatment to disease progression or death, whichever occurred first, and progression was determined based on contrast-enhanced CT or MRI scans following mRECIST criteria

  Up to 24 months after baseline MRI

Interventions

time-dependent diffusion MRI and Cest sequence OTHER

Time-dependent Diffusion MRI： This is a specialized MRI technique that measures water molecule diffusion at different time intervals to probe tissue microstructural features. In tumor tissues with dense cellularity and complex architecture, water diffusion is restricted. This technique allows for the detection of changes in cell size, shape, and interstitial spaces in liver cancer, providing insights into tumor heterogeneity and microenvironment. CEST (Chemical Exchange Saturation Transfer)： This is a molecular imaging technique based on chemical exchange. It selectively saturates exchangeable protons on specific molecules (such as proteins, peptides, or metabolites) and detects the transfer of this saturation effect to water protons, enabling indirect measurement of specific molecule concentrations in vivo. In liver cancer research, CEST can detect protein content, pH changes, and metabolic abnormalities in tumor tissues, providing functional information to assess tumor biological be

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with suspected primary HCC detected on ultrasound or CT at our institution or referring hospitals were prospectively enrolled. All participants underwent EOB-MRI, including Td-dMRI and conventional sequences.

You may qualify if:

• age 18 years or older, (b) pathologically confirmed HCC with available pathology slides, and (c) EOB-MRI including Td-dMRI within 1 month before surgery.

You may not qualify if:

• (a) lesions smaller than 1 cm, (b) poor imaging quality, and (c) received other treatments before surgery.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

zhen li, PHD

CONTACT

+86 130 3717 8109; zhenli@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

CN (1)