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Radiation Therapy

Yttrium-90 Radioembolization for Liver Cancer

N/A

Waitlist Available

Led By Armeen Mahvash

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test in premenopausal women

Patients over 18 years of age, of any race or sex, who have unresectable hepatocellular carcinoma of the liver, and who are able or have a fully able legal guardian to give informed consent

Must not have

Active uncontrolled infection

Contraindications to angiography and selective visceral catheterization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will use personalized dose plans to improve Y90 treatments for liver cancer, aiming to improve patient outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to angiography and catheterization procedures such as bleeding or infection at the insertion site; abdominal pain; nausea; fatigue; potential damage to non-target organs if microspheres deviate from their intended path.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

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I am over 18 with liver cancer that cannot be surgically removed and can consent to treatment.

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I can care for myself and doctors expect me to live 3 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have severe liver or lung problems.

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I do not have any health conditions that would make TheraSphere® treatment unsafe for me.

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My cancer outside the liver is threatening my life.

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My treatment plan involves high-dose radiation to the lungs.

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My tumor is spreading into nearby tissues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor objective response rate (ORR)

Secondary study objectives

Accuracy of published tumor dose response prediction based on the yttrium-90 (Y90) tumor dose volume histograms

Changes in Common Terminology Criteria for Adverse Events (CTCAE) incidence

Changes in liver function

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (personalized radioembolization, SPECT/CT HIDA)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~320