ClinicalTrials.gg
RecruitingNCT05953961REALMUpdated Aug 3, 2025

90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

An interventional study of Therasphere 90Y and Microwave Ablation in Carcinoma, Hepatocellular, sponsored by Ochsner Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Ochsner Health System · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 926 studies in Carcinoma, Hepatocellular with a site in United States — 160 open to participants now, 245 under way, 17 of them phase 3. Carcinoma, Hepatocellular · United States.

Planned enrollment
308th of 775
50 · median 36
Started
2023
with 45 others
No phase
124 of 926
26 open now
Primary completion
2026-08
later than 52 of 244 live
Registered
806th of 926
by date

Among the 926 studies in Carcinoma, Hepatocellular with a site in United States, this one is the 308th largest by planned enrollment of the 775 interventional ones that give a count, is one of 46 that started in 2023, is one of 124 with no phase, reaches primary completion later than 52 of the 244 other live ones, and was the 806th registered.

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

160 of the 926 studies in Carcinoma, Hepatocellular with a site in United States are open now. Recruiting first, the newest first:

155 more — sign in →

All 160 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 736 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 30 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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). 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.

03

Conditions studied

  • Carcinoma, Hepatocellular

Keywords

  • Yttrium-90
  • Hypoalbuminemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • score 0 - 1
  • A - B
  • \< 2.5 mg/dL
  • Creatinine \< 2.0 mg/dL
  • No prior liver-directed therapy or systemic therapy for HCC
  • Solitary, unresectable HCC ≤ 3cm
  • Albumin level \< 3.4 g/dL at HCC diagnosis
  • Tumor anatomical location and angiosome amendable to MWA and 90Y

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Concurrent
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Therasphere Transarterial Radioembolization

    Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.

    Device: Therasphere 90Y

  • Active comparator
    Microwave Ablation

    Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.

    Device: Microwave Ablation

Interventions

  • DeviceTherasphere 90Y

    Transarterial Radioembolization

  • DeviceMicrowave Ablation

    Microwave Ablation

06

What researchers measure

Primary outcomes

  1. Disease Progression

    Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm

    Time frame: 1-year

Secondary outcomes

  1. Target Response Evaluation Criteria in Solid Tumors modified for HCC

    Durable target tumor response rate

    Time frame: 60 - 120 days post-treatment

  2. Time to Retreatment

    Duration of time following the first cycle treatment until the targeted tumor requires additional treatment

    Time frame: 1 year

  3. Duration of Response

    Duration of time after first cycle treatment the target tumor continues to respond to treatment

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Ochsner Main Campus
    New Orleans, Louisiana 70121, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for Aug 2026, 36 months after the start.

Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 36 months is below that.

Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2023
First posted
Jul 20, 2023
StartActual
Aug 8, 2023
Primary completionEst.
Aug 2026
CompletionEst.
Jan 2027
Last update
Aug 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05953961
Lead sponsor
Ochsner Health System
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Aug 8, 2023
Primary completion
Aug 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 3, 2025

Study contacts

Ken Bode
Contact
ken.bode@ochsner.org
5048421936
Amy Riehm
Contact
amyriehm@ochsner.org
5047039065
Ari Cohen, MD
principal investigator · Ochsner Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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