Clinical trial · Observational
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.
Integrative Multimodal Imaging and Multi-omics Profiling of HCC Heterogeneity: a Translational Exploratory Study Leveraging CEUS, Elastography, SMI, PAI, Multi-omics Analysis, and AI-driven Modeling to Advance Precision Diagnosis and Therapeutic Optimization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Intrahepatic Cholangiocarcinoma (ICC) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-modal ultrasonic imaging system for liver cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tumor progression or follow-up failure.
- timeFrame
- From date of enrollment until the date of first documented tumor progression, assessed up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 and ≤70 years; 2. Both sexes eligible; 3. Diagnosed with primary HCC or ICC; 4. Scheduled for surgical resection or conversion therapy; 5. Pathologically confirmed HCC/ICC via surgery or biopsy; 6. Posterior margin of the lesion ≤ 8 cm from the skin surface. Exclusion Criteria: 1. Pregnancy, lactation, or planned pregnancy during the study period; 2. History of other malignancies; 3. Cardiac, pulmonary, cerebral, or renal insufficiency; 4. Lesion depth \>8 cm from the skin surface on ultrasound; 5. Massive ascites; 6. Poor compliance (e.g., inability to hold breath during examination); 7. Allergy to ultrasound contrast agents.
References
Publications (0)
Data not yet available