Clinical trial NCT05111795: Holmium-166 Retrospective Collection of Real-World Data
Official title: Holmium-166 Retrospective Collection of Real-World Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Metastatic Cancer
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and Severity of Adverse Events
timeFrame: 30 months
measure: Progression Free Survival (PFS)
timeFrame: 30 months
measure: Hepatic Progression Free Survival (HPFS)
timeFrame: 30 months
measure: Overall survival (OS)
timeFrame: 30 months
measure: Tumor response in the liver
timeFrame: 3 months
measure: Lung shunt prediction
timeFrame: 1 month
Secondary outcomes:
measure: Administered activity
timeFrame: 1 month
measure: Liver volume treated
timeFrame: 1 month
measure: SIRT treatment approach
timeFrame: 1 month
measure: Tumor absorbed dose
timeFrame: 1 month
measure: Normal liver absorbed dose
timeFrame: 1 month
measure: The use of Q-SuiteTM in clinical practice
timeFrame: 1 month
measure: Number of patients downstaged to liver resection or liver transplantation
timeFrame: 30 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Aalst
country: Belgium
facility: OLV Aalst
city: Bruxelles
country: Belgium
facility: CUB Hôpital Erasme
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Herford
country: Germany
facility: Klinikum Herford
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Rome
country: Italy
facility: IFO IRCCS - Istituto Nazionale Tumori Regina Elena
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Porto
country: Portugal
facility: Instituto Português De Oncologia Do Porto Francisco Gentil, EPE
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
References: