Liver CancerREAD90YNCT03516695
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
An observational study of Liver Cancer, run by Boston Scientific Corporation at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- TheraSphere®
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 23 Feb 2018to 12 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with liver cancer for whom treatment with TheraSphere® has been prescribed and who meet all study eligibility criteria will be enrolled.
Who may be able to join
- 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
Who cannot join
- Participant who has previously received Y90 microspheres
- Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Rush University Medical Center
Chicago, Illinois, 60612
University of Miami
Coral Gables, Florida, 33146
Indiana University
Indianapolis, Indiana, 46202
UCLA
Los Angeles, California, 90095
Allina Health System Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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
- Conditions
- Liver Cancer
- Being tested
- TheraSphere®
- Keywords
- Registry, Liver Cancers, HCC, Dosimetry, Simplicit90Y™, TheraSphere®
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere®Device
Intra-arterial Yttrium-90 glass microspheres
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months follow up post last TheraSphere® treatment
Secondary outcomes (3)
Serious adverse events
Serious adverse events assessed as related or possibly related to TheraSphere®.
Measured: 6 months follow up post last TheraSphere® treatment
Adverse events of interest
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.
Measured: 6 months follow up post last TheraSphere® treatment
TheraSphere® Dosimetry in the subgroup of HCC participants
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.
Measured: From up to 30 days until the date of TheraSphere® Treatment and Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start23 Feb 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Why it stopped: due to Sponsor's ongoing and upcoming projects and overall research priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Sponsor
- Investigators
- Riccardo Lencioni, MD, Principal investigator, University of Miami (previously known affiliation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516695
- Sponsor's protocol ID
- BTG-007509-01
- Acronym
- READ90Y
- Status last verified
- Apr 2021
- First submitted
- 22 Mar 2018
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
- ClinicalTrials.gov ID
- NCT03516695
- Acronym / sponsor ID
- READ90Y / BTG-007509-01
- Conditions
- Liver Cancer
- Keywords
- Registry, Liver Cancers, HCC, Dosimetry, Simplicit90Y™, TheraSphere®
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to Sponsor's ongoing and upcoming projects and overall research priorities
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Biocompatibles UK Ltd
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with liver cancer for whom treatment with TheraSphere® has been prescribed and who meet all study eligibility criteria will be enrolled.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participant who has previously received Y90 microspheres
- Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphere®Intra-arterial Yttrium-90 glass microspheres | Device | – |
Primary outcome
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.
3 secondary outcomes
Serious adverse events
Time frame: 6 months follow up post last TheraSphere® treatment
Adverse events of interest
Time frame: 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
Results and safety
The study was stopped early (reason given: due to Sponsor's ongoing and upcoming projects and overall research priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Lencioni, MD principal investigator
University of Miami (previously known affiliation)
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Boston Scientific Corporation at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to Sponsor's ongoing and upcoming projects and overall research priorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting (time frame: 12 months follow up post last TheraSphere® treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.