NCT04903548

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 8, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

March 24, 2026

Status Verified

November 1, 2024

Enrollment Period

3.8 years

First QC Date

September 22, 2020

Last Update Submit

March 20, 2026

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (14)

  • 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

Interventions

SIRT with Y-90 resin microspheresPROCEDURE

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sirtuins

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Group III Histone DeacetylasesHistone DeacetylasesAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesADP Ribose TransferasesPentosyltransferasesGlycosyltransferasesTransferasesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Parvez Mantry, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

May 26, 2021

Study Start

January 8, 2021

Primary Completion

October 18, 2024

Study Completion

October 18, 2024

Last Updated

March 24, 2026

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)