Trials / Recruiting
RecruitingNCT05967143
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)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 845 (estimated)
- Sponsor
- Sirtex Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision. The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SIRT | Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres. |
Timeline
- Start date
- 2023-06-19
- Primary completion
- 2028-06-01
- Completion
- 2029-06-01
- First posted
- 2023-08-01
- Last updated
- 2024-11-27
Locations
9 sites across 3 countries: France, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05967143. Inclusion in this directory is not an endorsement.