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Radiation

Yttrium-90 Radioembolization for Low Platelet Count Due to Liver Cirrhosis

N/A

Waitlist Available

Led By Riad Salem, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to screening and must not be breastfeeding

Adequate baseline organ function (with the exception of cirrhosis) as evidenced by normal BUN/Cr and electrolytes on screening chemistry

Must not have

History of prior partial splenic embolization (PSE) or splenectomy

History of allergy or sensitivity to TheraSphere® or its components

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will determine if Yttrium-90 radioembolization is safe and effective for treating thrombocytopenia.

Who is the study for?

Adults with liver cirrhosis or portal hypertension and low platelet counts (≤80 × 10^9/L) can join this trial. They should have a life expectancy over 6 months, be able to consent, not pregnant/breastfeeding, and have no history of certain treatments like splenic embolization or recent investigational therapies.

What is being tested?

The trial is testing the safety and effectiveness of TheraSphere® Yttrium-90 Glass Microspheres in managing thrombocytopenia associated with liver cirrhosis. It involves using radioembolization to target the liver area.

What are the potential side effects?

Possible side effects include reactions related to angiography (like bleeding), sensitivity to the microsphere components, organ inflammation due to radiation exposure, and general discomfort from the procedure.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant or breastfeeding and have a recent negative pregnancy test.

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My kidney function is normal, except for cirrhosis.

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I am able to get out of my bed or chair and move around.

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My spleen is enlarged as shown by an imaging test.

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I have cirrhosis or portal hypertension with low platelets.

Exclusion Criteria

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

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I have had surgery or a procedure on my spleen.

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I am allergic to TheraSphere® or its ingredients.

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I cannot undergo certain blood vessel imaging tests due to bleeding risks that can't be fixed with treatment.

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I have a bleeding disorder not caused by liver disease.

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I am currently receiving chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Asses the need for Technetium albumin aggregated (TC-MAA 99m) injection to determine shunting prior to Y90 administration

Safety of 90Y RE for the treatment of thrombocytopenia in the setting of cirrhosis.

Safety of 90Y Radioembolization (RE) for the treatment of thrombocytopenia in the setting of cirrhosis, evaluated by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Secondary study objectives

Evaluate length of hospital stay after procedure

Evaluate platelet count 6 months after treatment

Evaluate splenic volume post procedure