Hepatocellular CarcinomaNCT04903548
Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres
An observational study of Hepatocellular Carcinoma, run by Methodist Health System at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SIRT with Y-90 resin microspheres
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 18 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: 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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SIRT with Y-90 resin microspheres
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRT with Y-90 resin microspheresProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographics
Patient demographics
Measured: May 2020 - 2022
Volumes for liver to be treated
liver volume prior to treatment
Measured: May 2020 - 2022
Lobe/segment to be treated
treatment location
Measured: May 2020 - 2022
Tumor volume
volume of tumor prior to treatment
Measured: May 2020 - 2022
Lung Shunt
Lung shunt presence
Measured: May 2020 - 2022
Tumor to normal ratio Tumor to Normal ratio prior to greatment
T:N
Measured: May 2020 - 2022
Severity of liver disease
Child-Pugh score
Measured: May 2020 - 2022
Liver synthetic function
ALBI (albumin-bilirubin) score
Measured: May 2020 - 2022
Objective response rate
using modified response evaluation criteria in solid tumors
Measured: May 2020 - 2022
Progression-free survival
Progression-free survival
Measured: May 2020 - 2022
Overall survival
Overall survival
Measured: May 2020 - 2022
Hospital-based charges/costs
Hospital-based charges/costs
Measured: 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)
Measured: May 2020 - 2022
SPECT CT
for missed Y90 administrations or extrahepatic Y90
Measured: May 2020 - 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start8 Jan 2021
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parvez Mantry, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903548
- Sponsor's protocol ID
- 017.HEP.2020.D
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Segmental/Super Selective Treatment Utilizing Flex-dosing in Treating Unresectable HCC With Y90 SIR-Spheres
- ClinicalTrials.gov ID
- NCT04903548
- Acronym / sponsor ID
- 017.HEP.2020.D
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIRT with Y-90 resin microspheresSelective 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 | Procedure or surgery | – |
Primary outcome
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
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
Severity of liver disease
Time frame: May 2020 - 2022
Child-Pugh score
Liver synthetic function
Time frame: May 2020 - 2022
ALBI (albumin-bilirubin) score
Objective response rate
Time frame: May 2020 - 2022
using modified response evaluation criteria in solid tumors
Progression-free survival
Time frame: May 2020 - 2022
Progression-free survival
Overall survival
Time frame: May 2020 - 2022
Overall survival
Hospital-based charges/costs
Time frame: May 2020 - 2022
Hospital-based charges/costs
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)
SPECT CT
Time frame: May 2020 - 2022
for missed Y90 administrations or extrahepatic Y90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parvez Mantry, MD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient demographics (time frame: May 2020 - 2022). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.