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Embolization Agent

LC Bead LUMI + TAE/RFA for Liver Cancer

Q: Is registration for this trial open at present?

<p>According to clinicaltrials.gov, this particular trial is no longer accepting participants. The study was first made public on December 1st 2016 and last updated November 3rd 2022. Despite the closed status of this medical research project, there are still 797 other trials recruiting patients at present time.</p>

Q: Is the utilization of LC Bead LUMI associated with any health risks?

<p>The safety of LC Bead LUMI was provisionally assigned a score of two as this is still in the Phase 2 stage, meaning there are some data supporting its security but no evidence indicating efficacy.</p>

Phase 2

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the imaging characteristic of radiopaque beads including qualitatively comparing virtual and actual bead perfusion in evaluating tumor vascularity in the treatment of hepatic tumors using bead embolization.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2Experimental Treatment2 Interventions

Treatment of hepatic tumors using bead embolization

Group II: 1Experimental Treatment3 Interventions

Treatment of hepatic tumors using bead embolization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAE

2010

N/A

~260

RFA

2014

Completed Phase 2

~1650

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

881,168 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)

7 Previous Clinical Trials

4,048 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 — Phase 2

Liver Cancer Research Study Groups: 1, 2

Liver Cancer Clinical Trial 2023: LC Bead LUMI Highlights & Side Effects. Trial Name: NCT02649868 — Phase 2

LC Bead LUMI (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649868 — Phase 2

Frequently Asked Questions

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

Is registration for this trial open at present?

"According to clinicaltrials.gov, this particular trial is no longer accepting participants. The study was first made public on December 1st 2016 and last updated November 3rd 2022. Despite the closed status of this medical research project, there are still 797 other trials recruiting patients at present time."

Answered by AI

Is the utilization of LC Bead LUMI associated with any health risks?

"The safety of LC Bead LUMI was provisionally assigned a score of two as this is still in the Phase 2 stage, meaning there are some data supporting its security but no evidence indicating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation

2016. "LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02649868.

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