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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

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ClinicalTrials.gov Identifier: NCT02649868
Recruitment Status : Enrolling by invitation
First Posted : January 8, 2016
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

Liver cancer begins in the cells of the liver. It can be treated with chemotherapy, radiation, or even a liver transplant. A less invasive treatment may be able to help some people with liver cancer. It is called percutaneous transarterial embolization (TAE). For TAE, a material is injected into blood vessels to block the blood flow that is feeding the tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or cooking tumors with needles that deliver heat by electricity or microwave.

Objective:

To test an embolization material called an 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.

Eligibility:

Adults 18 85 years old who have been diagnosed with liver cancer

Design:

Participants will have routine blood tests, physical exams, and x-rays.

Participants will be screened with blood tests, physical exam, and medical history. They will have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast drink and a contrast (dye) injected in the veins.

Participants will be admitted to the clinic. They will repeat the screening tests.

Participants may have other tests. These may include x-rays, other scans, or ultrasound.

Participants will be evaluated for general anesthesia.

They will get counseling about the procedure.

Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The beads contain iodine, which makes them visible by x-ray and by a CT scan machine.

Participants will have follow-up visits for 12 months. They will have CT scans and/or other radiologic tests.


Condition or disease Intervention/treatment Phase
Hepatic Cancer Liver Neoplasms Hepatocellular Cancer Liver Cancer Procedure: TAE Radiation: RFA Device: LC Bead LUMI Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Using 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
Actual Study Start Date : January 12, 2016
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: 1
Treatment of hepatic tumors using bead embolization.
Procedure: TAE
Transarterial embolization

Radiation: RFA
Thermal ablation

Device: LC Bead LUMI
LC Bead LUMI has been designed as a radiopaque version of the LC Bead

Experimental: 2
Treatment of hepatic tumors using bead embolization
Procedure: TAE
Transarterial embolization

Device: LC Bead LUMI
LC Bead LUMI has been designed as a radiopaque version of the LC Bead




Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
    No statistical analysis is required to power this trial, as it is a pilot feasibility study, and the outcomes related to imaging features will not be statistically analyzed, other than simple descriptive statistics.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients who are determined to be eligible for TAE by an interventional radiologist and the primary/referring team will be eligible for the study.
  • Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE.
  • Extent of hepatic metastases is <50% of total hepatic volume.
  • At least >=18 years of age: Because it is exceeding rare for someone under the age of 18 to develop hepatocellular carcinoma, we will exclude patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
  • ECOG performance status 0-2
  • Six months since last treatment with Y90
  • Patients must have normal or adequate organ and marrow function as defined below:

    • Hematology/Absolute Neutrophil Count/ > 1500 / mm3 without help of Filgrastim or other stimulating growth factors
    • Hematology/Platelet Count Patient eligible if platelet count is correctable to >=50,000/mm3
    • Hematology/Hemoglobin Patient eligible if hemoglobin count is correctable to >= 8.0 g/dl
    • Serum Chemistry/ALT/AST <= 5 times the upper limit of normal; except in the presence of obstructive liver metastases where ALT/AST may be up to 10 times the upper limit of normal
    • Serum Chemistry/Creatinine <1.5x institution upper limit of normal OR creatinine clearance >= 45mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
    • Serum Chemistry/Total Bilirubin <=3 mg/dl
    • Serum Chemistry/Prothrombin Time within 2 seconds of the upper limit of normal (INR<=1.8)
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.

EXCLUSION CRITERIA:

  • No contraindications to receive iodine products.
  • Main Portal Vein Occlusion or other contraindications to chemoembolization
  • Patients taking immunosuppressive drugs or unable to come off of ongoing chronic anticoagulation will not be eligible.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection with systemic manifestations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649868


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Bradford J Wood, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02649868    
Other Study ID Numbers: 160049
16-CC-0049
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 5, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .not yet known if there will be a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
Radio-Opaque Bland Beads
Thermal Ablation
Transarterial Embolization
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type