RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry

NCT03516695 | Terminated

• 1 other identifier: BTG-007509-01
• Study Type: observational
• Target: 95
• Locations: 2 countries
• Sites: 8

Brief Summary

This study is a non-interventional, observational, prospective, and global participant data registry. The study will collect effectiveness and safety data from approximately 1000 participants with liver cancers treated with TheraSphere® in a real-life setting from multiple centers globally. The absorbed dose to tumor and normal tissue will be calculated using the Simplicit90Y™ software in the subgroup of hepatocellular carcinoma (HCC) participants.

Conditions

Liver Cancer

Keywords

Registry; Liver Cancers; HCC; Dosimetry; Simplicit90Y™; TheraSphere®

Outcome Measures

Primary Outcomes (1)

• Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting

  Tumor response to TheraSphere® treatment will be assessed using Modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 depending on tumor type.

  12 months follow up post last TheraSphere® treatment

Secondary Outcomes (3)

• Serious adverse events

  6 months follow up post last TheraSphere® treatment

• Adverse events of interest

  6 months follow up post last TheraSphere® treatment

• TheraSphere® Dosimetry in the subgroup of HCC participants

  From up to 30 days until the date of TheraSphere® Treatment and Baseline

Interventions

TheraSphere® DEVICE

Intra-arterial Yttrium-90 glass microspheres

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

Participants with liver cancer for whom treatment with TheraSphere® has been prescribed and who meet all study eligibility criteria will be enrolled.

You may qualify if:

• Participant is ≥ 18 years of age
• Participant has confirmed liver cancer
• Participant is able to provide informed consent according to local requirements/law
• Participant has a life expectancy of ≥ 3 months
• Participant is scheduled to receive TheraSphere® treatment

You may not qualify if:

• Participant who has previously received Y90 microspheres
• Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (8)

UCLA

Los Angeles, California, 90095, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Allina Health System Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Riccardo Lencioni, MD

  University of Miami (previously known affiliation)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: May 4, 2018
• Study Start: February 23, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

US (7); CA (1)