Holmium-166 Retrospective Collection of Real-World Data

Hepatocellular Carcinoma Clinical Trial

— RECORD  

Official title:

Holmium-166 Retrospective Collection of Real-World Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111795
• Other study ID #: T141E4
• Status: Completed
• Start date: January 17, 2022
• Est. completion date: April 8, 2022

Study information

• Verified date: August 2022
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: April 8, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Device:
• Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres
SIRT work-up procedure and SIRT procedure

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	OLV Aalst	Aalst
Belgium	CUB Hôpital Erasme	Bruxelles
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	Klinikum Herford	Herford
Germany	Universitätsklinikum Jena	Jena
Germany	Universitätsmedizin Rostock	Rostock
Italy	IFO IRCCS - Istituto Nazionale Tumori Regina Elena	Rome
Netherlands	University Medical Center Utrecht	Utrecht
Portugal	Instituto Português De Oncologia Do Porto Francisco Gentil, EPE	Porto
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and Severity of Adverse Events	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.	30 months
Primary	Progression Free Survival (PFS)	Time from SIRT procedure until overall progression or death	30 months
Primary	Hepatic Progression Free Survival (HPFS)	Time from SIRT procedure until progression in the liver or death	30 months
Primary	Overall survival (OS)	Time from SIRT procedure until death from any cause	30 months
Primary	Tumor response in the liver	Response as per routine practice following the guidelines for corresponding tumor type	3 months
Primary	Lung shunt prediction	Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose	1 month
Secondary	Administered activity	The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres.	1 month
Secondary	Liver volume treated	The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.	1 month
Secondary	SIRT treatment approach	The technical performance of SIRT in term of treatment approach (selective, lobar, bi-lobar, whole liver) with QuiremSpheresTM Holmium-166 Microspheres.	1 month
Secondary	Tumor absorbed dose	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.	1 month
Secondary	Normal liver absorbed dose	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.	1 month
Secondary	The use of Q-SuiteTM in clinical practice	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.	1 month
Secondary	Number of patients downstaged to liver resection or liver transplantation	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	30 months