Radioembolization vs Microwave Ablation for Liver Cancer
(REALM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments for individuals with small, early-stage liver cancer and low protein levels in their blood. It compares radioembolization, which uses tiny radioactive beads to target the cancer, with microwave ablation, a method that uses heat to destroy cancer cells. The goal is to determine which treatment better prevents cancer progression in the first year. Individuals newly diagnosed with liver cancer, who have no previous liver treatments and a single tumor that cannot be surgically removed, might be suitable candidates. As an unphased trial, this study provides patients the chance to explore innovative treatment options that could potentially enhance their quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that microwave ablation (MWA) is safe and effective for treating liver cancer. It successfully removes tumors about 94.7% of the time, with a low recurrence rate of around 3.3% in the same area. This technique is minimally invasive, requiring no large cuts or incisions.
Research on 90-Yttrium (90Y) transarterial radioembolization has demonstrated its effectiveness in controlling liver tumors without causing serious side effects. Patients treated with 90Y experienced good local tumor control, and many studies have reported it as a safe option for those with liver cancer.
Both treatments have been well-tolerated by patients in earlier studies, showing promise as safe options for liver cancer treatment.12345Why are researchers excited about this trial's treatments?
Unlike traditional treatments for liver cancer, like surgical resection and conventional chemotherapy, the treatments being explored offer innovative approaches. Radioembolization with 90Y-Thorasphere involves using tiny glass microspheres infused with the radioactive isotope Yttrium-90, delivered directly into the tumor's blood supply. This allows for precise targeting of cancerous cells while sparing healthy tissue. On the other hand, microwave ablation uses a high-powered, gas-cooled multi-antenna system to generate intense heat, directly destroying tumor cells with an ablative margin greater than 5mm. Researchers are excited because these methods could lead to more effective, less invasive options with potentially quicker recovery times for patients.
What evidence suggests that this trial's treatments could be effective for liver cancer?
This trial will compare two treatments for liver cancer: microwave ablation (MWA) and 90Y transarterial radioembolization. Studies have shown that MWA effectively treats small liver cancers like hepatocellular carcinoma (HCC). One study found that MWA successfully destroyed most targeted tumors in 94.7% of cases, with a low recurrence rate of just 3.3%. Meanwhile, research on 90Y transarterial radioembolization indicates it effectively controls liver tumors. This method uses tiny radioactive beads to directly target and shrink tumors and has been used for over 20 years, known for managing liver cancer well without causing serious side effects. Participants in this trial will receive either MWA or 90Y transarterial radioembolization to evaluate their effectiveness.14678
Who Is on the Research Team?
Ari Cohen, MD
Principal Investigator
Ochsner Health
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either 90-Yittrium Therasphere transarterial radioembolization or microwave ablation as a first cycle liver-directed therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data collection on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging
What Are the Treatments Tested in This Trial?
Interventions
- 90Y Transarterial Radioembolization
- Microwave Ablation
90Y Transarterial Radioembolization is already approved in European Union, United States, Canada for the following indications:
- Hepatocellular carcinoma (HCC)
- Colorectal liver metastases (CRLM)
- Hepatocellular carcinoma (HCC)
- Colorectal liver metastases (CRLM)
- Hepatocellular carcinoma (HCC)
- Colorectal liver metastases (CRLM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ochsner Health System
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology