Hepatocellular CarcinomaNCT06798194
Fusing Ultrasound and Magnetic Resonance Imaging to Intelligently Plan Highly Conformal Ablation Thermal Field for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Thermal ablation is an important minimally invasive treatment for hepatocellular carcinoma (HCC), but local tumor progression (LTP) after ablation restricts the efficacy and status of ablation technology and seriously threatens patient survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Post-ablation MRI is used to evaluate whether the ablation area of the tumor is consistent with the highly conformal ablation thermal field provided by the AI model.
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2025to 30 Dec 2027
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients receiving ablation therapy
Who may be able to join
- Pathologically confirmed primary hepatocellular carcinoma
- Undergo curative ablation
- With complete clinical information and pre- and post-operative imaging information
Who cannot join
- Undergo palliative ablation
- Lack of clinical or imaging information
- Age less than 18 years
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
Chinese PLA Hospital
Beijing
Wenzhen Ding, +86 66939530, 923345765@qq.com
About this study
Thermal ablation is an important minimally invasive treatment for hepatocellular carcinoma (HCC), but local tumor progression (LTP) after ablation restricts the efficacy and status of ablation technology and seriously threatens patient survival. Insufficient coverage of thermal field is an important factor on the occurrence of LTP. Current thermal field planning relies on tumor contours and doctor experience, and the safety margin is uniform. Therefore, it cannot cope with the problem of insufficient coverage of thermal field caused by the different invasion capabilities of different tumors and different parts of the same tumor. This project intends to integratively analyze gray-scale ultrasound, contrast-enhanced ultrasound, magnetic resonance imaging and clinical information of HCC through deep canonical correlation analysis; summarize the prior knowledge of LTP risk factors in previous studies and perform conjoint analysis individual case data and common conclusions through knowledge graph; interpretatively predict the LTP risk and the high-risk LTP locations through link prediction; accurately predict the ablation safety margin required for different tumor parts through graph neural network, and achieve highly conformal thermal field planning based on different invasion capabilities to minimize the LTP risk of HCC. The project leverages tumor multi-modal imaging and prior knowledge as the entry point, performs highly conformal planning of the ablation thermal field through artificial intelligence technology, and provides a new method for precise ablation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Post-ablation MRI is used to evaluate whether the ablation area of the tumor is consistent with the highly conformal ablation thermal field provided by the AI model.
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-ablation MRI is used to evaluate whether the ablation area of the tumor is consistent with the highly conformal ablation thermal field provided by the AI model.Diagnostic test
This study developed an AI model that can provide optimal highly conformal ablation thermal field for HCC patients using ultrasound and MRI. Post-ablation MRI is used to evaluate whether the ablation area of the tumor is consistent with the highly conformal ablation thermal field provided by the AI model.
The patients were divided into:
- Actual ablation zone of the tumor was consistent with the highly conformal ablation thermal field (consistent group);
- Actual ablation zone of the tumor was inconsistent with the highly conformal ablation thermal field (inconsistent group).
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression
After HCC ablation, tumor recurrence appears around the ablation area
Measured: 2 years
Secondary outcomes (1)
tumor recurrence
Tumor recurrence after HCC ablation
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798194
- Sponsor's protocol ID
- Highly conformal ablation
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusing Ultrasound and Magnetic Resonance Imaging to Intelligently Plan Highly Conformal Ablation Thermal Field for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06798194
- Acronym / sponsor ID
- Highly conformal ablation
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Jan 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.
Thermal ablation is an important minimally invasive treatment for hepatocellular carcinoma (HCC), but local tumor progression (LTP) after ablation restricts the efficacy and status of ablation technology and seriously threatens patient survival. Insufficient coverage of thermal field is an important factor on the occurrence of LTP. Current thermal field planning relies on tumor contours and doctor experience, and the safety margin is uniform. Therefore, it cannot cope with the problem of insufficient coverage of thermal field caused by the different invasion capabilities of different tumors and different parts of the same tumor. This project intends to integratively analyze gray-scale ultrasound, contrast-enhanced ultrasound, magnetic resonance imaging and clinical information of HCC through deep canonical correlation analysis; summarize the prior knowledge of LTP risk factors in previous studies and perform conjoint analysis individual case data and common conclusions through knowledge graph; interpretatively predict the LTP risk and the high-risk LTP locations through link prediction; accurately predict the ablation safety margin required for different tumor parts through graph neural network, and achieve highly conformal thermal field planning based on different invasion capabilities to minimize the LTP risk of HCC. The project leverages tumor multi-modal imaging and prior knowledge as the entry point, performs highly conformal planning of the ablation thermal field through artificial intelligence technology, and provides a new method for precise ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients receiving ablation therapy
Key inclusion criteria (3 listed)
- Pathologically confirmed primary hepatocellular carcinoma
- Undergo curative ablation
- With complete clinical information and pre- and post-operative imaging information
Key exclusion criteria (3 listed)
- Undergo palliative ablation
- Lack of clinical or imaging information
- Age less than 18 years
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 |
|---|---|---|
| Post-ablation MRI is used to evaluate whether the ablation area of the tumor is consistent with the highly conformal ablation thermal field provided by the AI model.This study developed an AI model that can provide optimal highly conformal ablation thermal field for HCC patients using ultrasound and MRI. Post-ablation MRI is used to evaluate whether the ablation area of the tumor is consistent with the highly conformal ablation thermal field provided by the AI model. The patients were divided into: 1. Actual ablation zone of the tumor was consistent with the highly conformal ablation thermal field (consistent group); 2. Actual ablation zone of the tumor was inconsistent with the highly conformal ablation thermal field (inconsistent group). | Diagnostic test | – |
Primary outcome
Local tumor progression
Time frame: 2 years
After HCC ablation, tumor recurrence appears around the ablation area
1 secondary outcome
tumor recurrence
Time frame: 2 year
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 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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, run by Chinese PLA General 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Jan 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 Wenzhen Ding, Dr (+86 66939530, 923345765@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor progression (time frame: 2 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 29 Jan 2025.