Radioembolization for Liver Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day for subsequent patients, 2 visits over 2-4 weeks for first 2 patients

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

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 data supports the effectiveness of the treatment Yttrium Y 90 Resin Microspheres for liver cancer?

Yttrium-90 resin microsphere radioembolization has shown potential benefits in improving survival for patients with liver cancer, particularly in those with chemotherapy-resistant liver metastases, as it may offer survival gains compared to standard care. Additionally, it has been used successfully in treating primary liver tumors, with good outcomes reported in certain patient groups. ^{1 2 3 4 5}

Is radioembolization with Yttrium-90 safe for humans?

Radioembolization with Yttrium-90 microspheres is generally considered safe for treating liver cancer, though it can have side effects. These side effects can affect the liver and other parts of the body, but there are strategies to help prevent and manage them. ^{6 7 8 9 10}

How is the treatment Yttrium Y 90 Resin Microspheres unique for liver cancer?

Yttrium Y 90 Resin Microspheres is a unique treatment for liver cancer because it involves radioembolization, where tiny radioactive beads are delivered directly to the liver tumors through the blood vessels, providing targeted internal radiation. This method allows for high doses of radiation to be concentrated in the tumor while minimizing exposure to surrounding healthy tissue, which is different from traditional external radiation therapies. ^{2 11 12 13 14}

Research Team

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with liver cancer that has spread, who can understand and sign a consent form. It's suitable for those eligible for standard Y90 radioembolization treatment but not for patients where the cancer affects more than half of the liver.

Inclusion Criteria

The ability to understand and sign informed consent

You are eligible for a standard treatment called Y90 radioembolization for your liver tumors.

Exclusion Criteria

Patients with greater than 50% liver tumor burden

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients undergo diagnostic angiography and receive yttrium Y-90 radioembolization

1 day for subsequent patients, 2 visits over 2-4 weeks for first 2 patients

1 visit (in-person) for subsequent patients, 2 visits (in-person) for first 2 patients

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up at 1, 3, and 6 months

Treatment Details

Interventions

• Yttrium Y 90 Resin Microspheres

Trial Overview The study tests yttrium Y-90 radioembolization, which involves injecting radioactive particles into an artery to block blood flow to liver tumors. The focus is on doing this in one session to see if it's effective and more efficient.

Participant Groups

Group I: Treatment (angiography, yttrium Y-90 radioembolization) Experimental Treatment 7 Interventions

The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.

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

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]

Radioembolization with yttrium-90 microspheres is a safe and effective treatment for hepatic malignancies, primarily due to its tumor-killing radioactivity rather than causing ischemia.

The article reviews various side effects associated with radioembolization, including those common to all transarterial procedures, and discusses strategies to minimize these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of yttrium-90 radioembolization. Riaz, A., Awais, R., Salem, R.[2022]

Yttrium-90 (90Y) radioembolization is an effective catheter-based therapy that delivers targeted internal radiation directly to liver tumors using microspheres, either glass (TheraSphere®) or resin-based (SIR-Spheres®).

Clinical evidence supports the use of 90Y radioembolization for treating unresectable liver cancers, demonstrating its potential as a viable option for patients with these malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of hepatocellular carcinoma and metastatic disease to the liver. Lewandowski, RJ., Salem, R.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

The MAAPE score in intermediate and advanced hepatocellular carcinoma treated with Yttrium-90 resin microsphere radioembolization. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Hepatic radioembolization with Yttrium-90 glass microspheres for treatment of primary liver cancer. [2006]

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

Radioembolization versus standard care of hepatic metastases: comparative retrospective cohort study of survival outcomes and adverse events in salvage patients. [2012]

4. United States 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. [2022]

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

Survival and pattern of tumor progression with yttrium-90 microsphere radioembolization in predominantly hepatitis B Asian patients with hepatocellular carcinoma. [2018]

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

Complications following radioembolization with yttrium-90 microspheres: a comprehensive literature review. [2009]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Side effects of yttrium-90 radioembolization. [2022]

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

Radioembolization using 90Y-resin microspheres for patients with advanced hepatocellular carcinoma. [2022]

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

Radioembolization with Yttrium-90 Microspheres for the Treatment of Liver Metastases of Pancreatic Adenocarcinoma: A Multicenter Analysis. [2019]

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

Recognizing and Managing Adverse Events in Y-90 Radioembolization. [2022]

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

Yttrium-90 radioembolization of hepatocellular carcinoma and metastatic disease to the liver. [2021]

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

Computer modeling of yttrium-90-microsphere transport in the hepatic arterial tree to improve clinical outcomes. [2010]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Determination of Radiation Absorbed Dose to Primary Liver Tumors and Normal Liver Tissue Using Post-Radioembolization (90)Y PET. [2022]

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

Salvage radioembolization of liver-dominant metastases with a resin-based microsphere: initial outcomes. [2016]