Holmium-166 Retrospective Collection of Real-World Data (RECORD)

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Metastatic Cancer
• Intervention / Treatment: Device: Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres

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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Terumo Europe N.V.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Neoplastic Processes; Carcinoma, Hepatocellular; Neoplasm Metastasis
• Other Study ID Numbers: T141E4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No