RecruitingNCT07101237

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


Sponsor

Peking Union Medical College Hospital

Enrollment

308 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria7

  • 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.

Interventions

DIAGNOSTIC_TESTMulti-modal ultrasonic imaging system for liver cancer

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.


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT07101237


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