Hepatocellular Carcinoma (HCC)NCT07101237
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.
An observational study of Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (ICC), Primary Liver Cancer
- What is being tested?
- Multi-modal ultrasonic imaging system for liver cancer
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with HCC and ICC who prepared for surgical resection or conversion therapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Meng Yang, Doctor, 86-01069155493, yangmeng_pumch@126.com
About this study
Official title: 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
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.
Read the detailed description
- Research Background Primary liver cancer, predominantly comprising hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), ranks as the third leading cause of cancer-related mortality. In China, approximately 70% of liver cancer patients are diagnosed at intermediate or advanced stages, where localized therapies such as surgery and ablation yield limited efficacy, and targeted therapies exhibit low overall response rates in advanced cases. This may be attributed to the heterogeneity of liver cancer, which manifests at multiple molecular levels-including genomic, transcriptomic, and metabolomic variations-both across individuals and within individual tumors. Such heterogeneity leads to divergent therapeutic responses and clinical outcomes among patients with identical pathological types and stages. Therefore, there is an urgent need to develop preoperative diagnostic methods capable of early assessment and prediction of tumor heterogeneity to guide precision clinical decision-making. Ultrasound is the preferred imaging modality for liver cancer screening due to its cost-effectiveness, safety and widespread clinical adoption. Contrast enhanced ultrasound (CEUS), the secondary guideline-recommended imaging technique for liver cancer diagnosis, offers economic and low-risk advantages compared to first-line recommendations like dynamic contrast-enhanced CT or MRI. Liver elastography has become a standard clinical tool for assessing cirrhosis. Photoacoustic imaging (PAI), an emerging non-invasive functional imaging technology, enables visualization of specific molecules based on their spectroscopic characteristics at designated wavelengths. Extensive studies have demonstrated the significant value of combined photoacoustic/ultrasound imaging in the diagnosis and prognostic evaluation of various cancers, including breast cancer and melanoma. This study aims to: (1) Conduct an observational investigation combining CEUS, elastography, and superb microvascular imaging (SMI) to collect imaging data; (2) Collect tumor specimens from participants for investigating heterogeneous protein characteristics in primary liver cancer organoids using PAI; (3) Analyze peripheral venous blood samples to study transcriptomic profiles. Artificial intelligence (AI) will be employed to establish prognostic models integrating ultrasound radiomics and tumor heterogeneity multi-omics features, providing novel insights for precision diagnosis and treatment of liver cancer.
- Research workflow
- Construction of a diagnostic and prognostic model for liver cancer based on multimodal imaging Ultrasound examinations will be performed by sonographers with over five years of abdominal ultrasound experience. All the imaging data will be recorded.During the procedure, patients will assume a supine position with a left lateral decubitus position. Conventional ultrasound, SMI, shear wave /strain elastography, and CEUS will be conducted. Baseline data will be collected preoperatively, followed by postoperative/post-conversion therapy follow-ups at 1/2/3/4/5/6, 9/12/15/18/21/24, and 30/36/42/48/54/60 months to gather additional imaging and clinical data.
- Screening of prognosis-related heterogeneous multi-omics features and development of risk assessment models in HCC/ICC Peripheral venous blood (6-10 mL) will be collected from HCC/ICC patients. Whole blood and serum samples will be preserved, with 3 mL of whole blood and serum stored at -80°C. Another 3 mL of whole blood will be lysed in 9 mL TRIzol and stored at -80°C for multi-omics analysis. Tumor specimens will also be preserved for multi-omics studies and organoid-based heterogeneous protein characterization. Prognosis-associated transcriptomic and proteomic features will be screened based on patient outcomes, and prognostic risk models will be constructed by integrating these multi-omics profiles with clinical characteristics.
- Development of a predictive model integrating multimodal imaging and tumor heterogeneity multi-omics features via novel knowledge transfer and model training strategies First, transfer learning method will be applied to adapt basic perceptual capabilities from HCC/ICC multimodal imaging data. Furthermore, deep interactive fusion of radiomic features and tumor heterogeneity multi-omics data will be performed to establish predictive models for degree of HCC/ICC differentiation, MVI and prognosis.
- Conditions
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (ICC), Primary Liver Cancer
- Being tested
- Multi-modal ultrasonic imaging system for liver cancer
- Keywords
- liver cancer, HCC, contrast-enhanced ultrasound (CEUS), elastography, superb microvascular imaging (SMI), photoacoustic imaging (PAI)
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal ultrasonic imaging system for liver cancerDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor progression or follow-up failure.
Tumor progression criteria:
- 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.
- Non-target lesions: Clear progression of existing non-target lesions and/or the emergence of one or more new lesions.
Measured: From date of enrollment until the date of first documented tumor progression, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Aug 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101237
- Sponsor's protocol ID
- Muti-omics liver cancer
- Status last verified
- Dec 2024
- First submitted
- 21 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07101237
- Acronym / sponsor ID
- Muti-omics liver cancer
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Research Background Primary liver cancer, predominantly comprising hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), ranks as the third leading cause of cancer-related mortality. In China, approximately 70% of liver cancer patients are diagnosed at intermediate or advanced stages, where localized therapies such as surgery and ablation yield limited efficacy, and targeted therapies exhibit low overall response rates in advanced cases. This may be attributed to the heterogeneity of liver cancer, which manifests at multiple molecular levels-including genomic, transcriptomic, and metabolomic variations-both across individuals and within individual tumors. Such heterogeneity leads to divergent therapeutic responses and clinical outcomes among patients with identical pathological types and stages. Therefore, there is an urgent need to develop preoperative diagnostic methods capable of early assessment and prediction of tumor heterogeneity to guide precision clinical decision-making. Ultrasound is the preferred imaging modality for liver cancer screening due to its cost-effectiveness, safety and widespread clinical adoption. Contrast enhanced ultrasound (CEUS), the secondary guideline-recommended imaging technique for liver cancer diagnosis, offers economic and low-risk advantages compared to first-line recommendations like dynamic contrast-enhanced CT or MRI. Liver elastography has become a standard clinical tool for assessing cirrhosis. Photoacoustic imaging (PAI), an emerging non-invasive functional imaging technology, enables visualization of specific molecules based on their spectroscopic characteristics at designated wavelengths. Extensive studies have demonstrated the significant value of combined photoacoustic/ultrasound imaging in the diagnosis and prognostic evaluation of various cancers, including breast cancer and melanoma. This study aims to: (1) Conduct an observational investigation combining CEUS, elastography, and superb microvascular imaging (SMI) to collect imaging data; (2) Collect tumor specimens from participants for investigating heterogeneous protein characteristics in primary liver cancer organoids using PAI; (3) Analyze peripheral venous blood samples to study transcriptomic profiles. Artificial intelligence (AI) will be employed to establish prognostic models integrating ultrasound radiomics and tumor heterogeneity multi-omics features, providing novel insights for precision diagnosis and treatment of liver cancer.
- Research workflow
- Construction of a diagnostic and prognostic model for liver cancer based on multimodal imaging Ultrasound examinations will be performed by sonographers with over five years of abdominal ultrasound experience. All the imaging data will be recorded.During the procedure, patients will assume a supine position with a left lateral decubitus position. Conventional ultrasound, SMI, shear wave /strain elastography, and CEUS will be conducted. Baseline data will be collected preoperatively, followed by postoperative/post-conversion therapy follow-ups at 1/2/3/4/5/6, 9/12/15/18/21/24, and 30/36/42/48/54/60 months to gather additional imaging and clinical data.
- Screening of prognosis-related heterogeneous multi-omics features and development of risk assessment models in HCC/ICC Peripheral venous blood (6-10 mL) will be collected from HCC/ICC patients. Whole blood and serum samples will be preserved, with 3 mL of whole blood and serum stored at -80°C. Another 3 mL of whole blood will be lysed in 9 mL TRIzol and stored at -80°C for multi-omics analysis. Tumor specimens will also be preserved for multi-omics studies and organoid-based heterogeneous protein characterization. Prognosis-associated transcriptomic and proteomic features will be screened based on patient outcomes, and prognostic risk models will be constructed by integrating these multi-omics profiles with clinical characteristics.
- Development of a predictive model integrating multimodal imaging and tumor heterogeneity multi-omics features via novel knowledge transfer and model training strategies First, transfer learning method will be applied to adapt basic perceptual capabilities from HCC/ICC multimodal imaging data. Furthermore, deep interactive fusion of radiomic features and tumor heterogeneity multi-omics data will be performed to establish predictive models for degree of HCC/ICC differentiation, MVI and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with HCC and ICC who prepared for surgical resection or conversion therapy
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal ultrasonic imaging system for liver cancerConventional 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. | Diagnostic test | – |
Primary outcome
tumor progression or follow-up failure.
Time frame: From date of enrollment until the date of first documented tumor progression, assessed up to 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Yang, Doctor (86-01060155493 ext. 8601060155493, yangmeng_pumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor progression or follow-up failure. (time frame: From date of enrollment until the date of first documented tumor progression, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.