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

Carcinoma, Hepatocellular Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

• NCT number: NCT06302400
• Study type: Interventional
• Source: Imperial College London
• Contact: Rohini Sharma, Professor
• Phone: 02033133720
• Email: r.sharma@imperial.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Completion date: February 2027