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Radiation

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

N/A

Recruiting

Led By Riad Salme, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Evaluate length of hospital stay after procedure

Evaluate platelet count 6 months after treatment

Evaluate splenic volume post procedure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with thrombocytopenia secondary to cirrhosisExperimental Treatment1 Intervention

Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,587 Previous Clinical Trials

917,041 Total Patients Enrolled

6 Trials studying Liver Cirrhosis

2,443 Patients Enrolled for Liver Cirrhosis

BTG International Inc.OTHER

42 Previous Clinical Trials

3,066 Total Patients Enrolled

Riad Salme, MDPrincipal InvestigatorNorthwestern University

Media Library

TheraSphere® Yttrium-90 Glass Microspheres (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03059030 — N/A

Liver Cirrhosis Research Study Groups: Subjects with thrombocytopenia secondary to cirrhosis

Liver Cirrhosis Clinical Trial 2023: TheraSphere® Yttrium-90 Glass Microspheres Highlights & Side Effects. Trial Name: NCT03059030 — N/A

TheraSphere® Yttrium-90 Glass Microspheres (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03059030 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count of this clinical trial?

"Affirmative, the clinicaltrials.gov registry indicates that this research is actively enrolling participants. This trial was initially submitted on March 16th 2017 and has since been updated on September 7th 2022. 20 volunteers must be recruited from 1 medical facility for the study to continue."

Answered by AI

Does this investigation accommodate elderly participants?

"This medical experiment necessitates that enrollees be aged between 18 and 99 years old. Separately, there are ninety-nine clinical trials for those below the age of majority and five hundred twenty seven for seniors above 65."

Answered by AI

Are new participants being accepted for this research study?

"Affirmative. Information hosted on clinicaltrials.gov verifies that recruitment for this medical study is underway; the trial was first posted on March 16th 2017 and updated most recently on September 7th 2022. A total of 20 patients need to be enrolled from 1 site."

Answered by AI

What criteria must one meet to participate in this investigation?

"This clinical trial is recruiting 20 people from ages 18 to 99 who have thrombocytopenia. Additional requirements are as follows: having an anticipated lifespan of over 6 months without treatment, any sex, coming from any ethnic or racial group and possessing a 0-2 ECOG Performance Status score."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Riad Salem 2017. "Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03059030.

All > Thrombocytopenia > Cirrhosis