Your session is about to expire
← Back to Search
Radiation
Radioembolization vs Microwave Ablation for Liver Cancer (REALM Trial)
N/A
Recruiting
Led By Ari Cohen, MD
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
REALM Trial Summary
This trial will compare outcomes after 1 year of treatment for early-stage HCC to determine if 90Y lowers risk of progression. Participants will receive either 90Y or MWA, then standard care.
Who is the study for?
This trial is for adults with a new diagnosis of small, early-stage liver cancer (HCC) who also have low blood protein levels (hypoalbuminemia). They should be in good physical condition and have liver function within certain limits. People can't join if they've had previous treatments for HCC or if their tumor size exceeds 3cm.Check my eligibility
What is being tested?
The study compares two treatments: injecting tiny radioactive beads called Therasphere 90Y into the liver's blood vessels versus using Microwave Ablation to heat and destroy the tumor. Patients will be randomly assigned to one treatment and then receive standard care.See study design
What are the potential side effects?
Possible side effects include abdominal pain, nausea, fatigue, fever after treatment (post-embolization syndrome), changes in liver function tests, and complications from the procedures like bleeding or damage to nearby organs.
REALM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Progression
Secondary outcome measures
Duration of Response
Target Response Evaluation Criteria in Solid Tumors modified for HCC
Time to Retreatment
REALM Trial Design
2Treatment groups
Active Control
Group I: Microwave AblationActive Control1 Intervention
Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm.
Group II: Therasphere Transarterial RadioembolizationActive Control1 Intervention
Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationIndustry Sponsor
720 Previous Clinical Trials
932,972 Total Patients Enrolled
9 Trials studying Hepatocellular Carcinoma
1,216 Patients Enrolled for Hepatocellular Carcinoma
Ochsner Health SystemLead Sponsor
93 Previous Clinical Trials
184,611 Total Patients Enrolled
Ari Cohen, MDPrincipal InvestigatorOchsner Health
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to join this medical experiment at the moment?
"Affirmative. The information posted on clinicaltrials.gov demonstrates that this experiment, which was initially made available on August 8th 2023, is actively recruiting participants. To complete the trial, 50 patients must be sourced from 1 medical center."
Answered by AI
How many patients are eligible to partake in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this research recruitment is still open for applications since it was first published on 8th August 2023 and last updated 11th October 2023. It requires 50 volunteers from a single medical site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger