Trials / Completed
CompletedNCT04903548
Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres
Evaluating the Effects of Segmental/Super Selective Treatment Utilizing Flex-dosing in Treating Unresectable HCC With Y90 SIR-Spheres
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Methodist Health System · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC).
Detailed description
The overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC). This study will enable physicians to be more precise in administering the correct radio-embolic dose, which will improve safety and efficacy of treatment while maintaining optimal dosing for tumor side effects. This study could potentially identify tumors earlier in the course of disease progression, which may result in more efficacious treatment and quality of life for patients. Earlier diagnosis and treatment may result in decreased costs. This is a prospective cohort registry study. The prospective study cases will include all eligible Y90 patients, who meet the inclusion criteria who are treated beginning in May 2020 to May 2022. Follow-up of patients included in study will continue as needed in order to evaluate survival outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SIRT with Y-90 resin microspheres | Selective internal radiation therapy (SIRT) with Y-90 resin microspheres (Y-90 resin SIRT) is an intra-arterial, catheter-based locoregional therapy that has been used to treat patients with unresectable HCC |
Timeline
- Start date
- 2021-01-08
- Primary completion
- 2024-10-18
- Completion
- 2024-10-18
- First posted
- 2021-05-26
- Last updated
- 2026-03-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04903548. Inclusion in this directory is not an endorsement.