QuiremSpheres Observational Study

NCT03563274 | Terminated

• 1 other identifier: T131E1
• Study Type: observational
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Liver, Cancer of, Non-Resectable

Keywords

Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres®

Outcome Measures

Primary Outcomes (2)

• Tumor response

  1\. Tumor response in the liver • Tumor response in liver for overall population and each tumor type, assessed 3 months after SIRT has been completed as per routine practice following the corresponding guidelines for each tumor type (e.g. RECIST, mRECIST, EASL)

  3 months

• Safety

  2\. Frequency and Severity of Adverse Events • Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) and all adverse device effects (ADE) occurring during and after treatment throughout follow up of patients. Severity of adverse events will be rated following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety assessment will also be based on routine blood tests with an emphasis on the liver function parameters obtained at baseline, after the SIRT procedure and throughout the follow up period.

  12 months

Secondary Outcomes (4)

• Time to progression in liver and overall

  12 months

• Progression free survival in liver and overall

  12 months

• Overall survival rate

  12 months

• Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…)

  12 months

Interventions

Selective Internal Radiation Therapy with QuiremSpheres® DEVICE

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.

Also known as: SIRT, Radioembolization

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

Patients with unresectable primary liver cancer or unresectable metastases in the liver.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (2)

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

UMC Utrecht

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Dragica Paunovic, MD

  Chief Medical Officer at Terumo Europe

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 20, 2018
• Study Start: June 21, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

DE (1); NL (1)