Holmium-166 Retrospective Collection of Real-World Data

NCT05111795 | Completed

• 1 other identifier: T141E4
• Study Type: observational
• Target: 146
• Locations: 7 countries
• Sites: 12

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.

Conditions

Hepatocellular Carcinoma; Metastatic Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Administered activity

  1 month

• Liver volume treated

  1 month

• SIRT treatment approach

  1 month

• Tumor absorbed dose

  1 month

• Normal liver absorbed dose

  1 month

Interventions

Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres DEVICE

SIRT work-up procedure and SIRT procedure

Also known as: SIRT, Radioembolization, TARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (12)

ASZ Aalst

Aalst, Belgium

Location

OLV Aalst

Aalst, Belgium

Location

CUB Hôpital Erasme

Brussels, Belgium

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Klinikum Herford

Herford, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

IFO IRCCS - Istituto Nazionale Tumori Regina Elena

Rome, Italy

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Instituto Português De Oncologia Do Porto Francisco Gentil, EPE

Porto, Portugal

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Location

Universitätsspital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 8, 2021
• Study Start: January 17, 2022
• Primary Completion: February 15, 2022
• Study Completion: April 8, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (1); BE (3); IT (1); DE (4); PT (1); CH (1)