Holmium-166 Retrospective Collection of Real-World Data

Completed

• Conditions: Metastatic Cancer; Hepatocellular Carcinoma

• Registration Number: NCT05111795
• Lead Sponsor: Terumo Europe N.V.

Brief Summary

The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

Detailed Description

This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-08
• Study Start: 2022-01-17
• Primary Completion: 2022-02-15
• Study Completion: 2022-04-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Patient with diagnosis of primary liver tumor or metastases in the liver.
• Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July 2021.
• Patient is ≥ 18 years.
• If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.

Exclusion Criteria

• Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic Progression Free Survival (HPFS)	30 months	Time from SIRT procedure until progression in the liver or death
Overall survival (OS)	30 months	Time from SIRT procedure until death from any cause
Progression Free Survival (PFS)	30 months	Time from SIRT procedure until overall progression or death
Lung shunt prediction	1 month	Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose
Frequency and Severity of Adverse Events	30 months	The primary safety endpoint is defined in terms of incidence of adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 3, or any grade of a predefined list of events stemming from risk management of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres.
Tumor response in the liver	3 months	Response as per routine practice following the guidelines for corresponding tumor type

Secondary Outcome Measures

Name	Time	Method
Liver volume treated	1 month	The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.
Tumor absorbed dose	1 month	The technical performance of SIRT in term of tumor absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.
Administered activity	1 month	The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres.
SIRT treatment approach	1 month	The technical performance of SIRT in term of treatment approach (selective, lobar, bi-lobar, whole liver) with QuiremSpheresTM Holmium-166 Microspheres.
Normal liver absorbed dose	1 month	The technical performance of SIRT in term of normal liver absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.
Number of patients downstaged to liver resection or liver transplantation	30 months	The number of patients downstaged to liver resection or liver transplantation will be reviewed based on the number of patients that underwent liver resection or liver transplantation after the SIRT procedure
The use of Q-SuiteTM in clinical practice	1 month	The use of Q-SuiteTM in clinical practice will be recorded based on the software which is mentioned in the description of treatment or the presence of a Q-SuiteTM generated report in the patient's medical file.

Trial Locations

Locations (12)

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Klinikum Herford; 🇩🇪 Herford, Germany

IFO IRCCS - Istituto Nazionale Tumori Regina Elena; 🇮🇹 Rome, Italy

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

CUB Hôpital Erasme; 🇧🇪 Bruxelles, Belgium

ASZ Aalst; 🇧🇪 Aalst, Belgium

OLV Aalst; 🇧🇪 Aalst, Belgium

Instituto Português De Oncologia Do Porto Francisco Gentil, EPE; 🇵🇹 Porto, Portugal

Universitätsmedizin Rostock; 🇩🇪 Rostock, Germany

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands