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Recruiting NCT07315633

NCT07315633 An Innovative CFD-based Dosimetry and Pre-treatment Planning Platform to Support Personalized Transarterial Therapies for Liver Cancer

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Clinical Trial Summary
NCT ID NCT07315633
Status Recruiting
Phase
Sponsor University Hospital, Ghent
Condition Hepatocellular Carcinoma (HCC)
Study Type OBSERVATIONAL
Enrollment 80 participants
Start Date 2025-09-23
Primary Completion 2029-09-22

Trial Parameters

Condition Hepatocellular Carcinoma (HCC)
Sponsor University Hospital, Ghent
Study Type OBSERVATIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-23
Completion 2029-09-22
Interventions
Endovascular treatment

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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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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