Carcinoma, HepatocellularREALMNCT05953961
90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
A study testing Therasphere 90Y and Microwave Ablation in people with Carcinoma, Hepatocellular, run by Ochsner Health System at 1 site in United States.
Trial summary
This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Therasphere 90Y and Microwave Ablation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
- Eastern Cooperative Oncology Group score 0 - 1
- Child-Pugh A - B
- Bilirubin < 2.5 mg/dL
- Creatinine < 2.0 mg/dL
- No prior liver-directed therapy or systemic therapy for HCC
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- Solitary, unresectable HCC ≤ 3cm
- Albumin level < 3.4 g/dL at HCC diagnosis
- Tumor anatomical location and angiosome amendable to MWA and 90Y
Who cannot join
- Pregnant women
- Concurrent malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ochsner Main Campus
New Orleans, Louisiana, 70121
Ken Bode, ken.bode@ochsner.org
About this study
Official title: Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.
Read the detailed description
This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.
The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Therasphere 90Y, Microwave Ablation
- Keywords
- Yttrium-90, Hypoalbuminemia
- Medical subject headings
- Carcinoma, Hepatocellular, Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therasphere 90YDevice
Transarterial Radioembolization
Microwave AblationDevice
Microwave Ablation
| Study group | Role | What they receive |
|---|---|---|
| Therasphere Transarterial Radioembolization | Active comparator | Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion. Receives: Device: Therasphere 90Y |
| Microwave Ablation | Active comparator | Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm. Receives: Device: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
Measured: 1-year
Secondary outcomes (3)
Target Response Evaluation Criteria in Solid Tumors modified for HCC
Durable target tumor response rate
Measured: 60 - 120 days post-treatment
Time to Retreatment
Duration of time following the first cycle treatment until the targeted tumor requires additional treatment
Measured: 1 year
Duration of Response
Duration of time after first cycle treatment the target tumor continues to respond to treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start8 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Ari Cohen, MD, Principal investigator, Ochsner Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953961
- Sponsor's protocol ID
- 2023.090
- Other IDs
- Sponsored Research Agreement
- Acronym
- REALM
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
- ClinicalTrials.gov ID
- NCT05953961
- Acronym / sponsor ID
- REALM / 2023.090
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Yttrium-90, Hypoalbuminemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Jul 2023 (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.
This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.
Detailed description
This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.
The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therasphere Transarterial Radioembolization | Active comparator | Device: Therasphere 90YTwo-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion. |
| Microwave Ablation | Active comparator | Device: Microwave AblationAblation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
- Eastern Cooperative Oncology Group score 0 - 1
- Child-Pugh A - B
- Bilirubin < 2.5 mg/dL
- Creatinine < 2.0 mg/dL
Key exclusion criteria (2 listed)
- Pregnant women
- Concurrent malignancy
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 |
|---|---|---|
| Therasphere 90YTransarterial Radioembolization | Device | Therasphere Transarterial Radioembolization |
| Microwave AblationMicrowave Ablation | Device | Microwave Ablation |
Primary outcome
Disease Progression
Time frame: 1-year
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
3 secondary outcomes
Target Response Evaluation Criteria in Solid Tumors modified for HCC
Time frame: 60 - 120 days post-treatment
Time to Retreatment
Time frame: 1 year
Duration of Response
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- 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.
Ari Cohen, MD principal investigator
Ochsner Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therasphere 90Y and Microwave Ablation in people with Carcinoma, Hepatocellular, run by Ochsner 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 9 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ken Bode (5048421936, ken.bode@ochsner.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Progression (time frame: 1-year). 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 3 Aug 2025.