Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC with Y90 SIR-Spheres
NCT ID: NCT04903548
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1 participants
OBSERVATIONAL
2021-01-08
2024-10-18
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* All patients diagnosed with unresectable HCC in two of fewer hepatic segments at MDMC who undergo at least one SIRT procedure with Y-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) will be included in data capture. HCC is considered unresectable if it is multifocal or bilobar, or if the patient has malignant portal vein thrombosis, portal hypertension, or decompensated liver disease (Child-Pugh B or C).
* Eligible cases for inclusion are those that would have undergone Y-90 resin SIRT and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; platelets \>60,000; creatinine \<2 mg/dL; bilirubin \<2 mg/dL; and international normalized ratio (INR) \<1.2.
* Patients are not eligible for SIRT if they had any extrahepatic disease; contraindication to hepatic artery catheterization such as vascular abnormalities, bleeding diathesis, allergy to contrast dye, concurrent malignancy, refractory ascites, previous external beam radiation, or evidence of any uncorrectable flow to the gastrointestinal tract; or greater than 30 Gy of radiation estimated to be delivered to the lung based on angiography or Tc-99 microaggregated albumin scan (shunt fraction of 20% or greater).
18 Years
ALL
No
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Parvez Mantry, MD
Role: PRINCIPAL_INVESTIGATOR
Methodist Health System
Locations
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Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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017.HEP.2020.D
Identifier Type: -
Identifier Source: org_study_id
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