MedTrace Logo

LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors

NCT02649868 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-07-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Hepatic Cancer
  • Liver Neoplasms
  • Hepatocellular Cancer
  • Liver Cancer

Interventions

PROCEDURE

Transarterial embolization (TAE)

Transarterial embolization

DEVICE

LC Bead LUMI

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

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Bradford J Wood, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2020-07-23
Completion
2020-07-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649868 on ClinicalTrials.gov