Radioembolization with EYE90 Microspheres for Liver Cancer

Recruiting at 23 trial locations

Overseen By ABK Biomedical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ABK Biomedical

Disqualifiers: Low platelets, High INR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for liver cancer called EYE90 Microspheres. The treatment uses tiny beads filled with radioactive material to directly target and shrink liver tumors. The trial aims to assess the effectiveness and safety of this approach for individuals with liver cancer that cannot be surgically removed. Those diagnosed with liver cancer, having up to three tumors, and no disease outside the liver might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in liver cancer treatment.

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.

What prior data suggests that this device is safe for treating liver cancer?

A previous study tested a treatment called radioembolization using EYE90 microspheres on six patients with liver cancer and found it safe. Researchers monitored these patients for six months and observed no serious safety issues. The treatment uses a radioactive material called yttrium-90 to target liver tumors directly. This method has been used before and has shown promising results in treating liver cancer. So far, patients have handled the treatment well, with no major side effects reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EYE90 Microspheres Treatment for liver cancer because it offers a unique approach compared to standard treatments like surgery, chemotherapy, and external radiation. Unlike traditional methods, this treatment involves radioembolization, where tiny radioactive beads (microspheres) are injected directly into the liver's blood vessels to target tumors with high precision. This method minimizes damage to healthy tissues and delivers radiation directly to the cancer cells, potentially leading to fewer side effects and improved outcomes. Additionally, by concentrating treatment at the tumor site, EYE90 Microspheres may offer a more effective option for patients whose cancer cannot be surgically removed.

What evidence suggests that Eye90 Microspheres is effective for liver cancer?

Research has shown that EYE90 microspheres can help treat liver cancer. One study demonstrated that delivering radiation directly to cancer cells using these microspheres was safe and effective for six patients with inoperable liver cancer over six months. Another study examined the long-term benefits of Y-90 radioembolization, the main component of EYE90, and found it improved liver function. This trial will evaluate the effectiveness of EYE90 microspheres as a treatment for liver tumors, building on these promising findings. ^{1 2 4 5 6}

Who Is on the Research Team?

Andrew Kennedy, MD

Principal Investigator

Director, Radiation Oncology Research at Sarah Cannon

Ammar Sarwar, MD

Principal Investigator

Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center

Aravind Arepally, MD

Principal Investigator

ABK Biomedical, Inc

Are You a Good Fit for This Trial?

This trial is for adults with unresectable Hepatocellular Carcinoma (HCC) who have a single liver tumor ≤ 8 cm or multiple tumors with a combined size of ≤ 12 cm. Participants must have at least one measurable lesion, no extra hepatic disease, and a life expectancy of over 6 months. They cannot join if they have severe kidney issues, blood disorders, compromised biliary systems, or are at risk for high radiation exposure to the lungs.

Inclusion Criteria

At least one lesion must be identified as a target lesion as defined by mRECIST

I have up to 3 cancer spots, with one being at least 2 cm big.

Hypervascular on CBCT, CT, or MRI

Exclusion Criteria

Platelet count <50,000/microliter or prothrombin (PT) activity > 50% normal

Bilirubin ≥ 2.0 mg/dL

AST > 5x upper limit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radioembolization with Eye90 Microspheres for the treatment of unresectable Hepatocellular Carcinoma

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EYE90 Microspheres Treatment

Trial Overview The study tests Eye90 microspheres®, which deliver targeted radiation directly to liver tumors using yttrium-90 (Y-90). The goal is to treat all lesions in one session and evaluate the effectiveness and safety of this local brachytherapy approach in patients with HCC.

How Is the Trial Designed?

Group I: EYE90 Microspheres Treatment Experimental Treatment 1 Intervention

Radioembolization with Eye90 Microspheres

EYE90 Microspheres Treatment is already approved in United States for the following indications:

Approved in United States as Eye90 Microspheres for:

• Hepatocellular Carcinoma (HCC)

Who Is Running the Clinical Trial?

ABK Biomedical

Lead Sponsor

Trials

2

Recruited

130+

Published Research Related to This Trial

In a study of 12 patients who underwent selective internal radiation therapy (SIRT) with Y90 microspheres, liver resection was found to be a viable option for some patients with unresectable tumors, potentially extending their overall survival.

Despite the high rates of perioperative morbidity (42%) and a 42% readmission rate, the procedure shows promise for selected patients, indicating that Y90 treatment can lead to favorable surgical outcomes in the context of multimodal therapy for liver cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90 is Safe and Feasible: A Bi-institutional Analysis. Wright, GP., Marsh, JW., Varma, MK., et al.[2018]

In a study of 46 patients with inoperable hepatocellular carcinoma, those who received transarterial radioembolization with yttrium-90 microspheres had significantly longer survival compared to those who did not receive the treatment, especially in patients with specific tumor characteristics.

While radioembolization showed promise in prolonging survival, it also led to side effects such as grade 2 irradiation-induced gastritis in 10% of patients and radioembolization-induced liver disease in 13%, indicating the need for careful monitoring and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival benefit of radioembolization for inoperable hepatocellular carcinoma using yttrium-90 microspheres. Kwok, PC., Leung, KC., Cheung, MT., et al.[2014]

Yttrium-90 microspheres are being increasingly utilized for treating both primary and secondary liver tumors, indicating their growing acceptance in clinical practice.

The article discusses over 900 radioembolization procedures conducted over 5 years, highlighting the need for further dialogue in the interventional oncology community regarding the complexities and controversies of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 2: special topics. Salem, R., Thurston, KG.[2022]

Yttrium-90 (Y90) microsphere treatment for patients with liver-dominant colorectal metastases showed a tumor response rate of 40.3% and a median overall survival of 14.5 months after treatment, indicating its efficacy in managing this condition.

The treatment was generally safe, with common side effects including fatigue (61%) and nausea (21%), and it was particularly beneficial for asymptomatic patients with good liver function, who had a median survival of 42.8 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres. Mulcahy, MF., Lewandowski, RJ., Ibrahim, SM., et al.[2022]

Microsphere-based radioembolization is a promising new treatment for diffuse or multifocal liver tumors, allowing targeted therapy directly to the liver via the hepatic artery, which is a significant advancement over traditional systemic therapies.

The standard method for this treatment involves using yttrium-90 glass or resin microspheres, which have shown effective therapeutic results in interventional oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Selective internal radiotherapy (SIRT) for hepatocellular carcinoma]. Antoch, G., Mueller, SP., Hamami, M., et al.[2010]

Yttrium-90 (Y90) radioembolization therapy using TheraSphere® has been deemed safe and effective for treating hepatocellular carcinoma (HCC), even in patients with portal vein thrombosis, according to the Radioembolization Brachytherapy Oncology Consortium.

Despite promising initial results, there are currently no randomized clinical trials demonstrating a survival benefit for TheraSphere®, indicating the need for further research before it can be fully recommended as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization for hepatocellular carcinoma using TheraSphere®. Ali, SM.[2021]

In a study of 4 patients with hepatocellular carcinoma and macrovascular invasion, Yttrium-90 microspheres radioembolization (Y90-RE) led to complete regression of thrombosis, allowing them to qualify for liver transplantation.

The procedure was safe, with no deaths reported during or after Y90-RE, and resulted in a disease-free survival of 39.1 months, suggesting that Y90-RE can be an effective downstaging treatment for patients with advanced liver cancer before transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocellular carcinoma with macrovascular invasion treated with yttrium-90 radioembolization prior to transplantation. Levi Sandri, GB., Ettorre, GM., Colasanti, M., et al.[2020]

In a pilot study involving 5 patients with liver tumors, PET/CT imaging successfully localized 90Y glass microspheres after radioembolization, demonstrating its effectiveness in confirming microsphere deposition.

No adverse events related to the treatment were reported, indicating that radioembolization with 90Y microspheres is a safe procedure for patients with hepatocellular carcinoma and liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal pair production of 90Y permits hepatic localization of microspheres using routine PET: proof of concept. Gates, VL., Esmail, AA., Marshall, K., et al.[2022]

Yttrium-90 (Y-90) microsphere therapy, also known as selective internal radiation therapy (SIRT), has been shown to effectively extend the time to disease progression and improve survival in patients with liver metastases from colorectal cancer (CRC).

This review compiles data from various clinical trials and studies, highlighting the methodology, outcomes, and side effects of Y-90 therapy, indicating its growing role as a treatment option for patients who are not candidates for surgery or have failed systemic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of hepatic metastases from colorectal cancer. Raval, M., Bande, D., Pillai, AK., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1051044324004366

Imageable Radioembolization Microspheres for Treatment ... Radioembolization using imageable microspheres was safe and effective in 6 subjects with unresectable HCC at 6-month interim analysis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10331743/

Long-term outcome analysis of Y90 radioembolization in ... This study aimed to evaluate a clinical real-world experience of Y90 effectiveness and long-term impact on hepatic function.

3. jvir.org jvir.org/article/S1051-0443(23)01080-1/fulltext

6-Month Interim Safety and Efficacy and 3- ... To describe 6-month safety and efficacy and 3-month liver volume changes after multimodal imageable glass Y-90 radioembolization for hepatocellular carcinoma ( ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT05953337

Radioembolization Trial Utilizing Eye90 Microspheres™ for ... This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with ...

5. abkbiomedical.com abkbiomedical.com/research/abk-first-time-in-human-study/

Eye90 Microspheres ® Clinical Development This study is assessing Eye90 microspheres for the treatment of patients with unresectable hepatocellular cancer (HCC) or metastatic colorectal cancer (mCRC)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278188/

Yttrium-90 microsphere therapy for hepatocellular carcinoma CLINICAL OUTCOMES. The clinical outcomes of Y-90 microsphere therapy in patients with unresectable HCC have demonstrated promising results.