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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be differences in how tumor cells and liver cells respond to radiation. Personalized dose plans may help improve treatment and outcomes in liver cancer.

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 data supports the effectiveness of the treatment Yttrium-90 Microsphere Radioembolization for liver cancer?

Research shows that Yttrium-90 microsphere therapy, also known as Selective Internal Radiation Therapy (SIRT), can improve outcomes for patients with inoperable liver cancer by delivering targeted radiation to tumors while sparing healthy liver tissue. Studies have reported successful results in treating both primary liver cancer and liver metastases, indicating its potential effectiveness. ^{1 2 3 4 5}

Is Yttrium-90 Radioembolization safe for humans?

Yttrium-90 Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), has been used in treating liver cancer and other liver tumors. It delivers high doses of radiation directly to the tumor while minimizing exposure to healthy liver tissue, suggesting a focus on safety. However, like any medical treatment, it may have side effects, and its safety profile should be discussed with a healthcare provider. ^{1 3 4 5 6}

How is Yttrium-90 Radioembolization treatment different from other liver cancer treatments?

Yttrium-90 Radioembolization is unique because it delivers high doses of radiation directly to liver tumors through the blood vessels, minimizing exposure to healthy liver tissue. This targeted approach combines radiation therapy with embolization (blocking blood flow to the tumor), making it different from traditional chemotherapy or external radiation treatments. ^{1 2 3 4 5}

Research Team

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Serbia 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. [2019]

4. Italy 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. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Radioembolization for hepatocellular carcinoma using TheraSphere®. [2021]