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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres | Device | SIRT work-up procedure and SIRT procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Progression Free Survival (PFS) | Time from SIRT procedure until overall progression or death | 30 months |
| Hepatic Progression Free Survival (HPFS) | Time from SIRT procedure until progression in the liver or death | 30 months |
| Overall survival (OS) | Time from SIRT procedure until death from any cause | 30 months |
| Tumor response in the liver | Response as per routine practice following the guidelines for corresponding tumor type | 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Administered activity | The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres. | 1 month |
| Liver volume treated |
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Inclusion Criteria:
Exclusion Criteria:
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The population to be included has been treated at the top-ordering hospitals for QuiremSpheresTM Holmium-166 Microspheres. All patients treated at these hospitals between 15 July 2019 and 15 July 2021 are aimed to be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASZ Aalst | Aalst | Belgium | ||||
| OLV Aalst |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.
| 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. | 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. | 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. | 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. | 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 | 30 months |
| Aalst |
| Belgium |
| CUB Hôpital Erasme | Brussels | Belgium |
| Universitätsklinikum Carl Gustav Carus | 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 |
| Hospital Universitari Germans Trias i Pujol | Barcelona | Spain |
| Universitätsspital Basel | Basel | Switzerland |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |