An Exploratory Study on Developing an Integrated Approach Combining Multimodal Imaging and Multi-omics Characterization of Tumor Heterogeneity for Precision Diagnosis and Treatment Optimization in Liver Cancer.

NCT07101237 | Recruiting

• 1 other identifier: Muti-omics liver cancer
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

Primary liver cancer, mainly including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), represents the third leading cause of cancer-related mortality. Enhancing the precision of liver cancer diagnosis and providing early therapeutic efficacy and prognostic evaluation during clinical decision-making hold significant clinical importance. Ultrasound is the preferred imaging modality for liver cancer screening. Contrast-enhanced ultrasound (CEUS) can dynamically visualize the microvascular perfusion of liver cancer lesions. Liver elastography has become a commonly used clinical assessment tool for cirrhosis. Photoacoustic imaging (PAI), an emerging non-invasive functional imaging technique, enables visualization of specific molecules through their spectroscopic characteristics at designated wavelengths. The objectives of this study include: (1) Conducting an observational investigation combining CEUS, elastography, and superb microvascular imaging (SMI) to collect imaging data; (2) Preserving tumor specimens from participants to investigate heterogeneous protein characteristics of primary liver cancer organoids using PAI; (3) Analyzing peripheral venous blood samples to study transcriptomic profiles. Artificial intelligence (AI) technology will be employed to establish models integrating ultrasound radiomics with tumor multi-omics characteristics, aiming to provide novel strategies for precision diagnosis and treatment of liver cancer. Key questions：(1) How to develop a multimodal imaging model combining CEUS, elastography, and SMI for predicting differentiation of liver cancer, microvascular invasion (MVI) and prognosis; (2) Whether PAI can identify heterogeneous proteins in liver cancer organoids through specific spectral recognition; (3) Whether AI can integrate multi-dimensional data to establish models based on ultrasound radiomics and multi-omics features.

Conditions

Hepatocellular Carcinoma (HCC); Intrahepatic Cholangiocarcinoma (ICC); Primary Liver Cancer

Keywords

liver cancer; HCC; contrast-enhanced ultrasound (CEUS); elastography; superb microvascular imaging (SMI); photoacoustic imaging (PAI)

Outcome Measures

Primary Outcomes (1)

• tumor progression or follow-up failure.

  Tumor progression criteria: 1. Target lesions: Based on the smallest sum of the longest diameters recorded in the study, progression is defined as: a) A ≥ 20% increase in the sum of the longest diameters of target lesions, with an absolute increase of at least 5 mm, or b) The appearance of new lesions. 2. Non-target lesions: Clear progression of existing non-target lesions and/or the emergence of one or more new lesions.

  From date of enrollment until the date of first documented tumor progression, assessed up to 5 years

Interventions

Multi-modal ultrasonic imaging system for liver cancer DIAGNOSTIC_TEST

Conventional ultrasound, SMI, shear wave /strain elastography, and CEUS will be conducted for HCC/ICC patients. All above the imaging examinations will be conducted at 1/2/3/4/5/6, 9/12/15/18/21/24, and 30/36/42/48/54/60 months after the postoperative/post-conversion therapy.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with HCC and ICC who prepared for surgical resection or conversion therapy

You may qualify if:

• Age \>18 and ≤70 years;
• Both sexes eligible;
• Diagnosed with primary HCC or ICC;
• Scheduled for surgical resection or conversion therapy;
• Pathologically confirmed HCC/ICC via surgery or biopsy;
• Posterior margin of the lesion ≤ 8 cm from the skin surface.

You may not qualify if:

• Pregnancy, lactation, or planned pregnancy during the study period;
• History of other malignancies;
• Cardiac, pulmonary, cerebral, or renal insufficiency;
• Lesion depth \>8 cm from the skin surface on ultrasound;
• Massive ascites;
• Poor compliance (e.g., inability to hold breath during examination);
• Allergy to ultrasound contrast agents.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Meng Yang, Doctor

CONTACT

86-01060155493; yangmeng_pumch@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 3, 2025

Record last verified: 2024-12

Locations

CN (1)