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

Boston Scientific

Status: Terminated

Conditions: Liver Cancer

Treatments: Device: TheraSphere®

Study type: Observational

Funder types: Industry

Identifiers

NCT03516695

BTG-007509-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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