NCT05953961 90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
| NCT ID | NCT05953961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ochsner Health System |
| Condition | Carcinoma, Hepatocellular |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-08-08 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-08-08 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 * 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 * 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: * Pregnant women * Concurrent malignancy
Contact & Investigator
Ari Cohen, MD
PRINCIPAL INVESTIGATOR
Ochsner Health
Frequently Asked Questions
Who can join the NCT05953961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Hepatocellular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05953961 currently recruiting?
Yes, NCT05953961 is actively recruiting participants. Contact the research team at ken.bode@ochsner.org for enrollment information.
Where is the NCT05953961 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT05953961 clinical trial?
NCT05953961 is sponsored by Ochsner Health System. The principal investigator is Ari Cohen, MD at Ochsner Health. The trial plans to enroll 50 participants.