Evaluating the Effects of Segmental/Super Selective Treatment Utilizing Flex-dosing in Treating Unresectable HCC With Y90 SIR-Spheres
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Methodist Health System
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Patient demographics
Study Overview
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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).
Outcomes
Primary Outcomes
Patient demographics
Time Frame: May 2020 - 2022
Patient demographics
Volumes for liver to be treated
Time Frame: May 2020 - 2022
liver volume prior to treatment
Lobe/segment to be treated
Time Frame: May 2020 - 2022
treatment location
Objective response rate
Time Frame: May 2020 - 2022
using modified response evaluation criteria in solid tumors
Tumor volume
Time Frame: May 2020 - 2022
volume of tumor prior to treatment
Lung Shunt
Time Frame: May 2020 - 2022
Lung shunt presence
Tumor to normal ratio Tumor to Normal ratio prior to greatment
Time Frame: May 2020 - 2022
T:N
Hospital-based charges/costs
Time Frame: May 2020 - 2022
Hospital-based charges/costs
Overall survival
Time Frame: May 2020 - 2022
Overall survival
SPECT CT
Time Frame: May 2020 - 2022
for missed Y90 administrations or extrahepatic Y90
Severity of liver disease
Time Frame: May 2020 - 2022
Child-Pugh score
Liver synthetic function
Time Frame: May 2020 - 2022
ALBI (albumin-bilirubin) score
Progression-free survival
Time Frame: May 2020 - 2022
Progression-free survival
Liver function tests
Time Frame: May 2020 - 2022
Measurement of Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Albumin and total protein, Bilirubin, Prothrombin time (PT), L-lactate dehydrogenase (LD), Gamma-glutamyltransferase (GGT)
Secondary Outcomes
No secondary outcomes reported