Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study

PRIMARY OBJECTIVES:

I. The principal objective of the RESIN registry is to evaluate response to therapy using
objective response criteria such as modified Response Evaluation Criteria in Solid Tumors
(mRECIST) or European Association for Study of the Liver (EASL). The response criteria used
will depend on tumor type treated and local policies as this is a registry and not a formal
research study. Secondary criteria include overall survival, time to progression (TTP) and
toxicity.

OUTLINE:

Patients receiving Yttrium Y90 resin microspheres treatment as part of their overall
oncologic management are added in the RESIN registry database to collect and document
information including: patient demographics (gender/age), previous oncologic treatments,
details of Yttrium Y90 resin microspheres treatment, and to track outcomes and complications.

Inclusion Criteria:

- Patients receiving SIR-Spheres therapy to the liver for the first time.

- Provision of written informed consent.

- Age 18 and older.

Exclusion Criteria:

1. Prior completion of Y90 therapy to the liver (SIR-Spheres, TheraSpheres, or any other
liver-targeted therapy involving the use of radiation-emitting spheres).

-Patients who have received Y90 treatment in the past and who are returning for
another Y90 treatment are ineligible, even if new areas are being targeted.

2. Need for surrogate consent. Patients unable to consent on their own behalves are not
eligible for this study.