About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age >18 and ≤70 years;
Both sexes eligible;
Diagnosed with primary HCC or ICC;
Scheduled for surgical resection or conversion therapy;
Disqualifiers
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;
Trial population
Patients diagnosed with HCC and ICC who prepared for surgical resection or conversion therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Multi-modal ultrasonic imaging system for liver cancer
Diagnostic testConventional 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.