Yttrium-90 Radioembolization for Liver Cancer

Overseen By Armeen Mahvash

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Severe liver dysfunction, Pulmonary insufficiency, Active infection, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2-4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Yttrium-90 radioembolization, which targets liver cancer by delivering radiation directly to tumors. Researchers aim to determine if personalizing the radiation dose for each patient can enhance the treatment's effectiveness. The trial includes individuals with liver cancer that cannot be surgically removed, particularly those with tumors at least 3 cm in size. Participants will undergo a special scan before and a few months after receiving the treatment to assess tumor response. This trial seeks individuals who have previously undergone treatments like chemotherapy and are ready for a new approach. As an unphased trial, it offers a unique opportunity to explore personalized treatment options that could potentially improve outcomes for liver cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you must be at least one month post-chemotherapy, which might imply a need to pause certain treatments. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that Yttrium-90 Microsphere Radioembolization is safe for liver cancer treatment?

Research has shown that Yttrium-90 radioembolization is a promising treatment for liver cancer, particularly hepatocellular carcinoma (HCC). Studies indicate that this treatment is generally safe and effective. Patients who received Yttrium-90 did not experience serious side effects or complications.

The treatment uses tiny radioactive beads to target cancer in the liver, aiming to control tumors and improve patient outcomes. Patients generally tolerate the procedure well, and clinical trials have found it to be a safe option for managing liver cancer.

Overall, for those considering joining a trial for this treatment, existing research suggests it has a good safety record and could be a viable option for treating liver cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for liver cancer, which often involve surgery, chemotherapy, or external radiation therapy, yttrium-90 radioembolization uses tiny glass microspheres loaded with the radioactive substance yttrium-90. This treatment is unique because it delivers targeted radiation directly to the tumor via the bloodstream, potentially minimizing damage to surrounding healthy tissue. Researchers are particularly excited about its personalized dosing approach, where the radiation dose is tailored to each patient's specific needs, potentially improving effectiveness and reducing side effects. Additionally, combining this approach with advanced imaging techniques, like SPECT/CT HIDA scans, helps monitor treatment impact more precisely.

What evidence suggests that Yttrium-90 Microsphere Radioembolization might be an effective treatment for liver cancer?

Research has shown that Yttrium-90 microsphere radioembolization, the treatment under study in this trial, effectively treats liver cancer, particularly hepatocellular carcinoma (HCC). Studies have found that this treatment controls tumors without causing serious side effects. It is especially beneficial for patients with HCC that cannot be surgically removed. Yttrium-90 radioembolization targets cancer cells directly in the liver, potentially leading to better patient outcomes. The treatment is also considered safe, making it generally suitable for patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with unresectable liver cancer (HCC), who haven't had recent radiation, surgery, or chemotherapy. They must have a life expectancy of at least 3 months and be in relatively good health otherwise. Pregnant women or those with severe liver dysfunction, lung risks, active infections, significant extrahepatic disease, or certain medical conditions can't participate.

Inclusion Criteria

It's been over a month since my last radiation, surgery, or chemotherapy.

At least one lesion >/= 3.0 cm in shortest dimension

I am not pregnant.

Exclusion Criteria

I currently have an infection that isn't under control.

I cannot undergo certain blood vessel imaging tests due to health risks.

I do not have severe liver or lung problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo yttrium-90 microsphere radioembolization with personalized dose measurements and SPECT/CT HIDA scan before radioembolization

2-4 months

Multiple visits for treatment and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, including SPECT/CT HIDA scan 2-4 months after radioembolization

6 months

Follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Yttrium-90 Microsphere Radioembolization

Trial Overview

The study tests personalized dosing of Yttrium-90 microsphere radioembolization for treating liver cancer. It aims to tailor the radiation dose to individual patient needs rather than using standard doses which may not account for how different tumors respond to treatment.

How Is the Trial Designed?

Group I: Treatment (personalized radioembolization, SPECT/CT HIDA) Experimental Treatment 5 Interventions

Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.

Yttrium-90 Microsphere Radioembolization is already approved in United States, European Union for the following indications:

Approved in United States as Yttrium-90 Microspheres for:

• Hepatocellular carcinoma
• Colorectal cancer liver metastases

Approved in European Union as Yttrium-90 Microspheres for:

• Hepatocellular carcinoma
• Colorectal cancer liver metastases

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 111 patients with unresectable hepatocellular carcinoma (HCC) treated with Y-90 resin microspheres, factors such as early-stage disease and absence of complications like portal vein thrombosis were linked to significantly longer overall survival, with patients in the early-stage group living an average of 27.8 months compared to just 9.2 months for those in advanced stages.

Y-90 resin treatment was generally well-tolerated, with adverse events reported in 23 patients shortly after treatment and 46 patients at 3 months, indicating that while some side effects occurred, the therapy was manageable and could be an effective option for bridging patients to liver transplantation, which further improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study. Mantry, PS., Mehta, A., Madani, B., et al.[2022]

In a study involving 34 patients with unresectable hepatocellular carcinoma (HCC), Yttrium-90 (Y-90) microsphere therapy demonstrated significant efficacy, with 19% achieving complete response and 44% showing partial response after treatment.

The therapy was found to be safe, with no serious side effects reported, and predictors of treatment success included mean tumor dose delivery and the absence of bilobar disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) resin microsphere therapy for patients with unresectable hepatocellular carcinoma. Identification of successful treatment response predictors and patient selection. Arslan, N., Ince, S., Okuyucu, K., et al.[2022]

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]

Selective internal radiotherapy (SIRT) using yttrium-90 microspheres can enhance clinical outcomes for patients with inoperable liver cancer by targeting tumors while protecting healthy tissue.

Effective planning for SIRT is crucial to avoid serious side effects like radiation-induced liver disease, and it is recommended to use multiple planning methods to determine the appropriate microsphere activity for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. Lau, WY., Kennedy, AS., Kim, YH., et al.[2022]

Selective intraarterial radionuclide therapy (SIRT) using Yttrium-90 microspheres is a safe and effective treatment for unresectable hepatic metastases from neuroendocrine tumors, with a high overall response rate of 90% in a study of 10 patients.

The treatment delivered a significant dose of radiation directly to the tumors (mean 99.73 Gy) while minimizing exposure to healthy liver tissue (mean 26.73 Gy) and lungs (mean 4.45 Gy), indicating its targeted approach reduces potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective intraarterial radionuclide therapy with Yttrium-90 (Y-90) microspheres for hepatic neuroendocrine metastases: initial experience at a single center. Arslan, N., Emi, M., Alagöz, E., et al.[2019]

In a study involving 28 patients with unresectable hepatocellular carcinoma (HCC), Y-90 microsphere therapy demonstrated safety and efficacy, with no significant complications observed during or shortly after treatment.

The therapy resulted in a complete response in 7% of patients and a partial response in 36%, indicating that it can effectively target liver tumors while minimizing damage to healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. İnce, S., Karaman, B., Alagoz, E., et al.[2019]

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