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

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).

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: SIRT with Y-90 resin microspheres

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	Patient demographics	May 2020 - 2022
Volumes for liver to be treated	liver volume prior to treatment	May 2020 - 2022
Lobe/segment to be treated	treatment location	May 2020 - 2022
Tumor volume	volume of tumor prior to treatment	May 2020 - 2022
Lung Shunt	Lung shunt presence	May 2020 - 2022
Tumor to normal ratio Tumor to Normal ratio prior to greatment	T:N	May 2020 - 2022
Severity of liver disease	Child-Pugh score	May 2020 - 2022
Liver synthetic function	ALBI (albumin-bilirubin) score	May 2020 - 2022
Objective response rate	using modified response evaluation criteria in solid tumors	May 2020 - 2022
Progression-free survival	Progression-free survival	May 2020 - 2022
Overall survival	Overall survival	May 2020 - 2022
Hospital-based charges/costs	Hospital-based charges/costs	May 2020 - 2022
Liver function tests	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)	May 2020 - 2022
SPECT CT	for missed Y90 administrations or extrahepatic Y90	May 2020 - 2022

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Parvez Mantry, MD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Amino Acids, Peptides, and Proteins; Proteins; Hydrolases; Enzymes; Enzymes and Coenzymes; Amidohydrolases; Transferases; Intracellular Signaling Peptides and Proteins; Glycosyltransferases; ADP Ribose Transferases; Pentosyltransferases; Group III Histone Deacetylases; Histone Deacetylases; Sirtuins
• Other Study ID Numbers: 017.HEP.2020.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No