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

Terumo

Status: Completed

Conditions: Metastatic Cancer; Hepatocellular Carcinoma

Treatments: Device: Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres

Study type: Observational

Funder types: Industry

Identifiers

NCT05111795

T141E4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.