RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry (READ90Y)

April 19, 2021 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Terminated

Conditions

Liver Cancer

Intervention / Treatment

Device: TheraSphere®

Detailed Description

This study is a non-interventional, observational, prospective and global participant data registry.

Approximately 1000 participants with liver cancers who are treated with TheraSphere® will be enrolled.

Data regarding participant and treatment characteristics (TheraSphere® and other anti-cancer treatments) will be collected within a 12-month period post TheraSphere® administration to:

Assess treatment effectiveness and safety in a real-life administration setting
Identify prognostic and predictive factors for liver cancer participants receiving TheraSphere® treatment

Data for dosimetry determination will be collected on approximately 300 HCC participants to assess:

Technetium-99m Macroaggregated albumin (99mTc-MAA) normal tissue and tumor Absorbed Dose using pre-procedural Single Proton Emission Computed Tomography/ Computed Tomography (SPECT/CT)
Yttrium-90 and isotopes (Y90) normal tissue and tumor Absorbed Dose using post-procedural PET/CT (or equivalent for Asia) scans

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2C8
    - University of Alberta
United States
- California
  - Los Angeles, California, United States, 90095
    - UCLA
- Florida
  - Coral Gables, Florida, United States, 33146
    - University of Miami
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - Regents of the University of Minnesota
  - Minneapolis, Minnesota, United States, 55407
    - Allina Health System Virginia Piper Cancer Institute
- New York
  - New York, New York, United States, 10016
    - New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting Time Frame: 12 months follow up post last TheraSphere® treatment	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events Time Frame: 6 months follow up post last TheraSphere® treatment	Serious adverse events assessed as related or possibly related to TheraSphere®.	6 months follow up post last TheraSphere® treatment
Adverse events of interest Time Frame: 6 months follow up post last TheraSphere® treatment	Specific adverse events assessed as related or possibly related to TheraSphere®, comprising of any of the following events: fatigue, pain, nausea, ascites, lymphopenia, hyperbilirubinemia, hypoalbuminemia.	6 months follow up post last TheraSphere® treatment
TheraSphere® Dosimetry in the subgroup of HCC participants Time Frame: From up to 30 days until the date of TheraSphere® Treatment and Baseline	Dose absorbed to normal tissue and tumor, using the pre TheraSphere® 99mTc-MAA SPECT/CT, will be examined and compared to post TheraSphere® Y90 PET/CT (or equivalent in Asia) using the Simplicit90Y™ software.	From up to 30 days until the date of TheraSphere® Treatment and Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Biocompatibles UK Ltd

Investigators

Principal Investigator: Riccardo Lencioni, MD, University of Miami (previously known affiliation)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Sponsor Website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BTG-007509-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.