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Embolization Agent

LC Bead LUMI + TAE/RFA for Liver Cancer

N/A

Waitlist Available

Led By Bradford J Wood, M.D.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

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

Must have

Extent of hepatic metastases is <50% of total hepatic volume

ECOG performance status 0-2

Must not have

Patients taking immunosuppressive drugs or unable to come off of ongoing chronic anticoagulation will not be eligible

Pregnant women and nursing mothers are excluded from this study because of the potential for teratogenic or abortifacient effects of required multiple imaging and associated radiation doses, anesthesia and risks during thermal ablation to the fetus. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-procedure

Awards & highlights

Summary

This trial is testing an embolization material called LC LUMI beads to see if it can block blood vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT images.

Who is the study for?

Adults aged 18-85 with liver cancer, suitable for TAE treatment, and meeting specific health criteria (e.g., adequate organ function) can join. Pregnant or nursing women, those on immunosuppressants or chronic anticoagulants, and individuals with certain medical conditions like main portal vein occlusion are excluded.

What is being tested?

The trial is testing LC Bead LUMI embolic beads in TAE procedures alone or combined with thermal ablation to treat liver tumors. The goal is to see if these beads can block tumor blood supply effectively while being visible on x-ray and CT scans.

What are the potential side effects?

Potential side effects may include reactions to the iodine in the beads, discomfort from the procedure itself, risks associated with anesthesia, and possible complications from blocking blood vessels such as changes in liver function.

Eligibility Criteria

Inclusion Criteria

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

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Less than half of my liver is affected by cancer.

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I can take care of myself and perform daily activities.

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My white blood cell count is above 1500 without needing medication to boost it.

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I am 18 years old or older.

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My kidney function tests are within the required range.

Exclusion Criteria

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

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I am not on immunosuppressive drugs or chronic anticoagulation that I can't stop.

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I am not pregnant or nursing and agree to use birth control during the study.

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I am not allergic to iodine products.

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I do not have any severe illnesses that would interfere with the study.

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I cannot have chemoembolization due to a blocked main portal vein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intra-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intra-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Perfusion Characteristics of Imageable Beads Using Cone Beam CT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hepatic tumors bead embolizationExperimental Treatment2 Interventions

Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

387 Previous Clinical Trials

879,892 Total Patients Enrolled

12 Trials studying Liver Cancer

524 Patients Enrolled for Liver Cancer

Bradford J Wood, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

8 Previous Clinical Trials

4,078 Total Patients Enrolled

2 Trials studying Liver Cancer

18 Patients Enrolled for Liver Cancer

Media Library

LC Bead LUMI (Embolization Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02649868 — N/A

Liver Cancer Research Study Groups: Hepatic tumors bead embolization

Liver Cancer Clinical Trial 2023: LC Bead LUMI Highlights & Side Effects. Trial Name: NCT02649868 — N/A

LC Bead LUMI (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649868 — N/A

~2 spots leftby Sep 2025

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