An Innovative CFD-based Dosimetry and Pre-treatment Planning Platform to Support Personalized Transarterial Therapies for Liver Cancer

NCT07315633 | Recruiting

• 1 other identifier: ONZ-2022-0334
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Cancer; Hepatocellular Carcinoma (HCC); Liver Cancer, Adult

Keywords

Hepatocellular carcinoma; Transarterial radioembolization; Computational Fluid Dynamics; Personalized medicine; Pre-treatment planning; Monte Carlo Dosimetry calculations

Outcome Measures

Primary Outcomes (3)

• 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

  4 years

• Identification of important procedure parameters

  Identification of key procedure parameters (e.g., catheter location, catheter direction, injection velocity) using the computational framework.

  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.

  4 years

Study Arms (1)

HCC patients who undergo TARE

Device: Endovascular treatment

Interventions

Endovascular treatment DEVICE

Endovascular treatment

HCC patients who undergo TARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with hepatocellular carcinoma who have underwent or will undergo TARE of the liver.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Elisabeth Dhondt, Dr.

CONTACT

+32 9 3326684; Elisabeth.dhondt@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 22, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 2, 2026

Record last verified: 2025-11

Locations

BE (1)