RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Quick Facts

Study Start:2023-08-08
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05953961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Eastern Cooperative Oncology Group score 0 - 1
  3. * Child-Pugh A - B
  4. * Bilirubin \< 2.5 mg/dL
  5. * Creatinine \< 2.0 mg/dL
  6. * No prior liver-directed therapy or systemic therapy for HCC
  7. * Solitary, unresectable HCC ≤ 3cm
  8. * Albumin level \< 3.4 g/dL at HCC diagnosis
  9. * Tumor anatomical location and angiosome amendable to MWA and 90Y
  1. * Pregnant women
  2. * Concurrent malignancy

Contacts and Locations

Study Contact

Ken Bode
CONTACT
5048421936
ken.bode@ochsner.org
Amy Riehm
CONTACT
5047039065
amyriehm@ochsner.org

Principal Investigator

Ari Cohen, MD
PRINCIPAL_INVESTIGATOR
Ochsner Health

Study Locations (Sites)

Ochsner Main Campus
New Orleans, Louisiana, 70121
United States

Collaborators and Investigators

Sponsor: Ochsner Health System

  • Ari Cohen, MD, PRINCIPAL_INVESTIGATOR, Ochsner Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-08-08
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Yttrium-90
  • Hypoalbuminemia

Additional Relevant MeSH Terms

  • Carcinoma, Hepatocellular