Hepatocellular Carcinoma (HCC)NCT07315633
An Innovative CFD-based Dosimetry and Pre-treatment Planning Platform to Support Personalized Transarterial Therapies for Liver Cancer
An observational study of Hepatocellular Carcinoma (HCC) and Liver Cancer, Adult, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Transarterial radioembolization (TARE) is a key treatment option for patients with unresectable hepatocellular carcinoma (HCC), a primary form of liver cancer. TARE is a minimally invasive therapy in which radioactive microspheres are delivered through a microcatheter near the tumour into the liver's blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Liver Cancer, Adult, Liver Cancer
- What is being tested?
- Endovascular treatment
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Sep 2025to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with hepatocellular carcinoma who have underwent or will undergo TARE of the liver.
Who may be able to join
- Subjects radiologically diagnosed with HCC, eligible for or undergoing treatment.
- Subjects who are treated (or will be treated) using TARE with radioactive microspheres.
- Subjects for whom pre-treatment medical imaging of the hepatic arterial vasculature was performed for TARE planning (e.g., CT, MRI, PET, SPECT, and DSA), which can be used to develop patient-specific 3D models of the hepatic arterial tree and treatment dose distribution.
Who cannot join
- Subjects undergoing TARE procedures without adequate medical imaging of the hepatic vasculature.
- Subjects in whom no pre- or post-treatment imaging data are available for analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Elisabeth Dhondt, Dr., +32 9 3326684, elisabeth.dhondt@uzgent.be
Elisabeth Dhondt, Dr.
About this study
Transarterial radioembolization (TARE) is a key treatment option for patients with unresectable hepatocellular carcinoma (HCC), a primary form of liver cancer. TARE is a minimally invasive therapy in which radioactive microspheres are delivered through a microcatheter near the tumour into the liver's blood vessels. Although TARE can significantly improve survival, treatment outcomes remain variable and difficult to predict, mainly because of complex liver vasculature and unpredictable distribution of radioactive microspheres due to uncertain parameters such as catheter tip location, catheter orientation, and injection velocity.
The long-term goal would be to make these treatments more predictable and effective by developing a patient-specific pre-treatment planning platform. Blood flow and microsphere transport will be modelled in a digital model of the patient-specific hepatic arterial tree (based on clinical imaging) using computational fluid dynamics (CFD), in combination with Monte Carlo-based radiation dosimetry. Using CFD simulations, we will investigate how variations in treatment parameters influence the microsphere distribution, aiming to better understand their role in treatment variability. This will allow us to predict the dose distribution of a certain treatment and determine potentially a more optimal set of treatment parameters. This research contributes to the broader field of cancer research by laying the foundations for a digital tool for personalized pre-treatment planning. The insights gained could support interventional radiologists in optimizing treatment planning, improving tumor targeting, and minimizing radiation exposure to healthy liver tissue in future TARE procedures.
Read the detailed description
TARE has become an established locoregional treatment for HCC, the most common form of primary liver cancer. During TARE, radioactive microspheres are injected through a microcatheter in the hepatic arteries to irradiate the tumor from within. The minimally invasive nature of this therapy makes it an important option for patients who are ineligible for surgery. However, despite its clinical relevance, treatment success remains variable between patients.
A challenge in TARE is the limited ability to predict how the injected microspheres will spread throughout the arterial network of the liver. As a result, microspheres do not always deposit homogenously within the tumor, and part of the injected dose may end up in healthy liver tissue. This may reduce treatment efficacy while increasing the risk of complications. Current pre-treatment planning and dosimetry approaches are not completely able to predict the resulting radiation dose.
The goal of this study is to develop a methodology that enables better understanding and prediction of microsphere distribution and radiation dose during TARE using patient-specific 3D models. These models will be constructed from clinical imaging data such as CT, MRI, PET, SPECT, or DSA, and will be used to analyze hepatic arterial anatomy and dose deposition patterns. By studying these relationships, the project aims to identify which anatomical and procedural factors influence microsphere transport and dose delivery, and how these insights can contribute to improved pre-treatment planning.
The clinical part of the study consists solely of collecting retrospective and prospective imaging and treatment data from patients undergoing TARE, without altering clinical workflow. Therefore, no additional risk or discomfort is introduced for participating patients. The collected data will serve as the foundation for developing and validating the 3D models. In the long term, the resulting insights may help optimize catheter positioning, injection parameters, and dose planning, with the ambition of achieving more effective, personalized, and safer TARE treatments.
- Being tested
- Endovascular treatment
- Keywords
- Hepatocellular carcinoma, Transarterial radioembolization, Computational Fluid Dynamics, Personalized medicine, Pre-treatment planning, Monte Carlo Dosimetry calculations
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentDevice
Endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| HCC patients who undergo TARE | Not described Receives: Device: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and validation of CFD models
Correlation coefficient between CFD-predicted and measured blood flow velocity, pressure distribution and particle distribution in an in vitro set-up
Measured: 4 years
Identification of important procedure parameters
Identification of key procedure parameters (e.g., catheter location, catheter direction, injection velocity) using the computational framework.
Measured: 4 years
Uncertainty on dose to tumor/healthy tissue
Quantifying the uncertainty on the calculated dose inside the patient due to the variation of the system parameters.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start23 Sep 2025
- Primary completion22 Sep 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.
- 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
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315633
- Sponsor's protocol ID
- ONZ-2022-0334
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative CFD-based Dosimetry and Pre-treatment Planning Platform to Support Personalized Transarterial Therapies for Liver Cancer
- ClinicalTrials.gov ID
- NCT07315633
- Acronym / sponsor ID
- ONZ-2022-0334
- Keywords
- Hepatocellular carcinoma, Transarterial radioembolization, Computational Fluid Dynamics, Personalized medicine, Pre-treatment planning, Monte Carlo Dosimetry calculations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 22 Sep 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Jan 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.
Transarterial radioembolization (TARE) is a key treatment option for patients with unresectable hepatocellular carcinoma (HCC), a primary form of liver cancer. TARE is a minimally invasive therapy in which radioactive microspheres are delivered through a microcatheter near the tumour into the liver's blood vessels. Although TARE can significantly improve survival, treatment outcomes remain variable and difficult to predict, mainly because of complex liver vasculature and unpredictable distribution of radioactive microspheres due to uncertain parameters such as catheter tip location, catheter orientation, and injection velocity.
The long-term goal would be to make these treatments more predictable and effective by developing a patient-specific pre-treatment planning platform. Blood flow and microsphere transport will be modelled in a digital model of the patient-specific hepatic arterial tree (based on clinical imaging) using computational fluid dynamics (CFD), in combination with Monte Carlo-based radiation dosimetry. Using CFD simulations, we will investigate how variations in treatment parameters influence the microsphere distribution, aiming to better understand their role in treatment variability. This will allow us to predict the dose distribution of a certain treatment and determine potentially a more optimal set of treatment parameters. This research contributes to the broader field of cancer research by laying the foundations for a digital tool for personalized pre-treatment planning. The insights gained could support interventional radiologists in optimizing treatment planning, improving tumor targeting, and minimizing radiation exposure to healthy liver tissue in future TARE procedures.
Detailed description
TARE has become an established locoregional treatment for HCC, the most common form of primary liver cancer. During TARE, radioactive microspheres are injected through a microcatheter in the hepatic arteries to irradiate the tumor from within. The minimally invasive nature of this therapy makes it an important option for patients who are ineligible for surgery. However, despite its clinical relevance, treatment success remains variable between patients.
A challenge in TARE is the limited ability to predict how the injected microspheres will spread throughout the arterial network of the liver. As a result, microspheres do not always deposit homogenously within the tumor, and part of the injected dose may end up in healthy liver tissue. This may reduce treatment efficacy while increasing the risk of complications. Current pre-treatment planning and dosimetry approaches are not completely able to predict the resulting radiation dose.
The goal of this study is to develop a methodology that enables better understanding and prediction of microsphere distribution and radiation dose during TARE using patient-specific 3D models. These models will be constructed from clinical imaging data such as CT, MRI, PET, SPECT, or DSA, and will be used to analyze hepatic arterial anatomy and dose deposition patterns. By studying these relationships, the project aims to identify which anatomical and procedural factors influence microsphere transport and dose delivery, and how these insights can contribute to improved pre-treatment planning.
The clinical part of the study consists solely of collecting retrospective and prospective imaging and treatment data from patients undergoing TARE, without altering clinical workflow. Therefore, no additional risk or discomfort is introduced for participating patients. The collected data will serve as the foundation for developing and validating the 3D models. In the long term, the resulting insights may help optimize catheter positioning, injection parameters, and dose planning, with the ambition of achieving more effective, personalized, and safer TARE treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients who undergo TARE | – | Device: Endovascular treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with hepatocellular carcinoma who have underwent or will undergo TARE of the liver.
Key inclusion criteria (3 listed)
- Subjects radiologically diagnosed with HCC, eligible for or undergoing treatment.
- Subjects who are treated (or will be treated) using TARE with radioactive microspheres.
- Subjects for whom pre-treatment medical imaging of the hepatic arterial vasculature was performed for TARE planning (e.g., CT, MRI, PET, SPECT, and DSA), which can be used to develop patient-specific 3D models of the hepatic arterial tree and treatment dose distribution.
Key exclusion criteria (2 listed)
- Subjects undergoing TARE procedures without adequate medical imaging of the hepatic vasculature.
- Subjects in whom no pre- or post-treatment imaging data are available for analysis.
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 |
|---|---|---|
| Endovascular treatmentEndovascular treatment | Device | HCC patients who undergo TARE |
Primary outcome
Accuracy and validation of CFD models
Time frame: 4 years
Correlation coefficient between CFD-predicted and measured blood flow velocity, pressure distribution and particle distribution in an in vitro set-up
Identification of important procedure parameters
Time frame: 4 years
Identification of key procedure parameters (e.g., catheter location, catheter direction, injection velocity) using the computational framework.
Uncertainty on dose to tumor/healthy tissue
Time frame: 4 years
Quantifying the uncertainty on the calculated dose inside the patient due to the variation of the system parameters.
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 2 Jan 2026.
- 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 (HCC) and Liver Cancer, Adult, run by University Hospital, Ghent at 1 site in Belgium.
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 2 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 2 Jan 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 Belgium. 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 Elisabeth Dhondt, Dr. (+32 9 3326684, Elisabeth.dhondt@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and validation of CFD models (time frame: 4 years). The study lists 3 primary outcomes in all. 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 2 Jan 2026.