Status:
COMPLETED
Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC with Y90 SIR-Spheres
Lead Sponsor:
Methodist Health System
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 segm...
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 segm...
Eligibility Criteria
Inclusion
- Age 18 years or older
- 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.
Exclusion
- Subjects that do not meet the inclusion criteria
- 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).
Key Trial Info
Start Date :
January 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04903548
Start Date
January 8 2021
End Date
October 18 2024
Last Update
November 18 2024
Active Locations (1)
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1
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203