Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302400
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-06
Brief Title:
Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RHEPaiR
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None