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.
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 Type
OBSERVATIONAL
Enrollment
146
SIRT work-up procedure and SIRT procedure
ASZ Aalst
Aalst, Belgium
OLV Aalst
Aalst, Belgium
CUB Hôpital Erasme
Brussels, Belgium
Universitätsklinikum Carl Gustav Carus
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.
Time frame: 30 months
Progression Free Survival (PFS)
Time from SIRT procedure until overall progression or death
Time frame: 30 months
Hepatic Progression Free Survival (HPFS)
Time from SIRT procedure until progression in the liver or death
Time frame: 30 months
Overall survival (OS)
Time from SIRT procedure until death from any cause
Time frame: 30 months
Tumor response in the liver
Response as per routine practice following the guidelines for corresponding tumor type
Time frame: 3 months
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
Time frame: 1 month
Administered activity
The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dresden, Germany
Klinikum Herford
Herford, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsmedizin Rostock
Rostock, Germany
IFO IRCCS - Istituto Nazionale Tumori Regina Elena
Rome, Italy
University Medical Center Utrecht
Utrecht, Netherlands
Instituto Português De Oncologia Do Porto Francisco Gentil, EPE
Porto, Portugal
...and 2 more locations
Liver volume treated
The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.
Time frame: 1 month
SIRT treatment approach
The technical performance of SIRT in term of treatment approach (selective, lobar, bi-lobar, whole liver) with QuiremSpheresTM Holmium-166 Microspheres.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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
Time frame: 30 months