Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
Sirtex Medical
845 participants
Jun 19, 2023
OBSERVATIONAL
Conditions
Summary
This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres
Eligibility
Inclusion Criteria7
- Age 18 years or older
- Confirmed diagnosis of:
- Unresectable hepatocellular carcinoma (HCC) Or
- Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy
- Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
- Planned to receive SIR-Spheres treatment to the liver for the first time
- Provision of signed patient informed consent
Exclusion Criteria5
- Prior radiation treatment to the liver
- Caveat:
- Sequential selective internal radiation therapy (SIRT) treatment is allowed
- Patients participating in any interventional clinical trial with an investigational product, device, or procedure
- Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
Interventions
Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05967143