Hepatocellular Carcinoma (HCC)NCT07838415
Multimodalomics-based Construction of Spatiotemporal Characteristics of Dynamic Liver Cancer Microenvironment to Characterize the Clinical Application of Immune Mechanisms in Liver Cancer
An observational study of Hepatocellular Carcinoma (HCC) and Treatment Response, run by Tongji Hospital at 1 site in China.
Trial summary
This study aims to explore whether adding an additional MRI sequence to routine liver scans can better characterize the immune microenvironment of liver cancer. We plan to prospectively enroll patients diagnosed with or suspected of having liver cancer who undergo routine MRI examinations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Treatment Response
- What is being tested?
- time-dependent diffusion MRI and Cest sequence
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to Jun 2028
- How long will I take part?
- 24 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with suspected primary HCC detected on ultrasound or CT at our institution or referring hospitals were prospectively enrolled. All participants underwent EOB-MRI, including Td-dMRI and conventional sequences.
Who may be able to join
- age 18 years or older, (b) pathologically confirmed HCC with available pathology slides, and (c) EOB-MRI including Td-dMRI within 1 month before surgery.
Who cannot join
- (a) lesions smaller than 1 cm, (b) poor imaging quality, and (c) received other treatments before surgery.
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
Tongji Hospital
Wuhan, Hubei, 430000
Zhen li, PHD, +86 130 3717 8109, zhenli@hust.edu.cn
About this study
This study aims to explore whether adding an additional MRI sequence to routine liver scans can better characterize the immune microenvironment of liver cancer. We plan to prospectively enroll patients diagnosed with or suspected of having liver cancer who undergo routine MRI examinations. In addition to the standard MRI protocol, participants will receive one extra MRI sequence. We will analyze the imaging features from this additional sequence and combine them with clinical data to construct a multi-omics model. The goal is to identify imaging biomarkers that can reflect the dynamic changes of the tumor microenvironment, which may help improve the diagnosis and clinical management of liver cancer.
- Conditions
- Hepatocellular Carcinoma (HCC), Treatment Response
- Being tested
- time-dependent diffusion MRI and Cest sequence
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-dependent diffusion MRI and Cest sequenceOther
Time-dependent Diffusion MRI： This is a specialized MRI technique that measures water molecule diffusion at different time intervals to probe tissue microstructural features. In tumor tissues with dense cellularity and complex architecture, water diffusion is restricted. This technique allows for the detection of changes in cell size, shape, and interstitial spaces in liver cancer, providing insights into tumor heterogeneity and microenvironment.
CEST (Chemical Exchange Saturation Transfer)： This is a molecular imaging technique based on chemical exchange. It selectively saturates exchangeable protons on specific molecules (such as proteins, peptides, or metabolites) and detects the transfer of this saturation effect to water protons, enabling indirect measurement of specific molecule concentrations in vivo. In liver cancer research, CEST can detect protein content, pH changes, and metabolic abnormalities in tumor tissues, providing functional information to assess tumor biological be
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of this study were PFS
PFS was calculated from the time of receiving treatment to disease progression or death, whichever occurred first, and progression was determined based on contrast-enhanced CT or MRI scans following mRECIST criteria
Measured: Up to 24 months after baseline MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Oct 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (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 Tongji 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
- 400 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Li, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838415
- Sponsor's protocol ID
- TJ-IRB202412046
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our institution maintains strict data security and patient privacy protection policies. Additionally, the sharing of clinical research data, particularly from studies involving human subjects, is subject to Chinese laws and regulations, including the Biosecurity Law and the Human Genetic Resources Management Regulations, which require institutional oversight and approval for any data transfer. We are committed to scientific transparency and are willing to share de-identified individual participant data upon reasonable request to the corresponding author, provided that such sharing is approved by our institutional review board and complies with all applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodalomics-based Construction of Spatiotemporal Characteristics of Dynamic Liver Cancer Microenvironment to Characterize the Clinical Application of Immune Mechanisms in Liver Cancer
- ClinicalTrials.gov ID
- NCT07838415
- Acronym / sponsor ID
- TJ-IRB202412046
- Conditions
- Hepatocellular Carcinoma (HCC), Treatment Response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Sep 2026 (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.
This study aims to explore whether adding an additional MRI sequence to routine liver scans can better characterize the immune microenvironment of liver cancer. We plan to prospectively enroll patients diagnosed with or suspected of having liver cancer who undergo routine MRI examinations. In addition to the standard MRI protocol, participants will receive one extra MRI sequence. We will analyze the imaging features from this additional sequence and combine them with clinical data to construct a multi-omics model. The goal is to identify imaging biomarkers that can reflect the dynamic changes of the tumor microenvironment, which may help improve the diagnosis and clinical management of liver cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with suspected primary HCC detected on ultrasound or CT at our institution or referring hospitals were prospectively enrolled. All participants underwent EOB-MRI, including Td-dMRI and conventional sequences.
Key inclusion criteria (1 listed)
- age 18 years or older, (b) pathologically confirmed HCC with available pathology slides, and (c) EOB-MRI including Td-dMRI within 1 month before surgery.
Key exclusion criteria (1 listed)
- (a) lesions smaller than 1 cm, (b) poor imaging quality, and (c) received other treatments before surgery.
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 |
|---|---|---|
| time-dependent diffusion MRI and Cest sequenceTime-dependent Diffusion MRI： This is a specialized MRI technique that measures water molecule diffusion at different time intervals to probe tissue microstructural features. In tumor tissues with dense cellularity and complex architecture, water diffusion is restricted. This technique allows for the detection of changes in cell size, shape, and interstitial spaces in liver cancer, providing insights into tumor heterogeneity and microenvironment. CEST (Chemical Exchange Saturation Transfer)： This is a molecular imaging technique based on chemical exchange. It selectively saturates exchangeable protons on specific molecules (such as proteins, peptides, or metabolites) and detects the transfer of this saturation effect to water protons, enabling indirect measurement of specific molecule concentrations in vivo. In liver cancer research, CEST can detect protein content, pH changes, and metabolic abnormalities in tumor tissues, providing functional information to assess tumor biological be | Other | – |
Primary outcome
The primary outcomes of this study were PFS
Time frame: Up to 24 months after baseline MRI
PFS was calculated from the time of receiving treatment to disease progression or death, whichever occurred first, and progression was determined based on contrast-enhanced CT or MRI scans following mRECIST criteria
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 24 Sep 2026.
- Individual participant dataSharing planned: Undecided. Our institution maintains strict data security and patient privacy protection policies. Additionally, the sharing of clinical research data, particularly from studies involving human subjects, is subject to Chinese laws and regulations, including the Biosecurity Law and the Human Genetic Resources Management Regulations, which require institutional oversight and approval for any data transfer. We are committed to scientific transparency and are willing to share de-identified individual participant data upon reasonable request to the corresponding author, provided that such sharing is approved by our institutional review board and complies with all applicable laws and regulations.
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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 Treatment Response, run by Tongji 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 1 inclusion and 1 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 24 Sep 2026. 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 zhen li, PHD (+86 130 3717 8109, zhenli@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes of this study were PFS (time frame: Up to 24 months after baseline MRI). 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 24 Sep 2026.