NCT06302400

Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma

Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma; a Multi-centre, Interventional, Non-randomized, Non-comparative, Open Label, Early Phase II Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are: * What is the safety and toxicity profile of the 166-Holmium microspheres? * Is the device effective in treating HCC? Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including: * A Computed Tomography (CT) scan * A Magnetic Resonance Imaging (MRI) scan * Blood tests * Quality of life questionnaires Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DEVICE	166Holmium microspheres (QuiremSpheres®)	QuiremSpheres® are a biocompatible microsphere that contain the radionuclide holmium-166 (166Ho), which emits gamma-radiation (81 keV) and high-energy (1.81 MeV) beta-particles.

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-03-04
• Completion: 2025-03-04
• First posted: 2024-03-08
• Last updated: 2025-09-19

Locations

1 site across 1 country: United Kingdom