QuiremSpheres Observational Study

NCT ID: NCT03563274

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2020-07-31

Brief Summary

The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.

Detailed Description

Liver tumors can be of primary (Hepatocellular Carcinoma, HCC) or metastatic (mainly from colorectal carcinoma, CRC) origin. Both HCC and CRC are common causes of death from cancer worldwide. The overall incidence of HCC and CRC remains high in developing countries and is steadily rising in most industrialized countries. Available treatment options depend on the size, number, and location of tumors, on liver status, overall performance status and comorbidities, on patency of portal vein and presence of extrahepatic metastatic disease. They include surgical (liver resection, liver transplantation), systemic (e.g. chemotherapy, immunotherapy), ablative (thermal ablation, chemical ablation) and intra-arterial (chemoembolization, radioembolization) modalities. Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) with microspheres containing a radiation-emitting isotope (Yttrium-90 or Holmium-166) delivers localized radiation in the vasculature around liver tumors with relatively limited concurrent injury to the surrounding normal/healthy tissue. Yttrium-90 radioembolization is currently included in several guidelines (EASLEORTC, ESMO).

Conditions

Liver, Cancer of, Non-Resectable

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Selective Internal Radiation Therapy with QuiremSpheres®

The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.

Intervention Type: DEVICE

Other Intervention Names

SIRT, Radioembolization

Eligibility Criteria

Inclusion Criteria

• Patient with diagnosis of primary liver tumor or metastases in the liver from other primary cancers, allocated to SIRT with QuiremSpheres® as decided by a multidisciplinary tumor board
• Patient is ≥ 18 years
• Patient has understood and signed written informed consent to data collection in the study

Exclusion Criteria

• Patient's refusal
• Local practice guidelines prohibiting the patient to receive SIRT

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dragica Paunovic, MD

Role: STUDY_DIRECTOR

Chief Medical Officer at Terumo Europe

Locations

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

UMC Utrecht

Utrecht, , Netherlands

Countries

Germany; Netherlands

Other Identifiers

T131E1

Identifier Type: -

Identifier Source: org_study_id