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

Not Applicable

Terminated

Conditions: Hepatic Cancer
Liver Cancer
Hepatocellular Cancer
Liver Neoplasms

Interventions: Procedure: Transarterial embolization (TAE)
Device: LC Bead LUMI

Registration Number: NCT02649868

Lead Sponsor: 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.

Detailed Description: Background:

Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide.

Management of hepatic malignancies from primary Hepatocellular Carcinoma (HCC) or metastatic disease involves a multidisciplinary approach of surgery and chemotherapy and in the case of HCC, transplant, anti-VEGF sorafenib, or local or regional image guided therapies.

Thermal ablation (RFA or MWA) and transarterial embolization (TAE) are minimally invasive image guided local or regional therapies that have been extensively studied for decades, and more recently and to a lesser extent have been studied together as a combination therapy.

LC Bead LUM\^TM, a radiopaque embolic bead product (company code BTG 13-002), is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g., fluoroscopy and CT).

The beads are non-resorbable microspheres with calibrated size ranges that occlude arteries for the purpose of blocking the blood flow to a target tissue.

LC Bead LUMITM are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Objectives:

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

Eligibility:

Treatment eligibility for TAE requires agreement between the Interventional Radiologist reviewing imaging and feasibility of TAE and the patient's NIH primary treatment team who will evaluate the patient's clinical parameters to undergo anesthesia and the TAE and or ablation procedure.

At least \>=18 years of age

Patients with pathologically proven, hepatic-dominant neoplasm.

The extent of hepatic metastases is \<50% of total hepatic volume.

Past treatment with Y90 must be 6 months from TAE treatment and liver function within NIH institutional limits

ECOG performance status \<=2

Patients must have normal organ and marrow function per laboratory parameters

Patients with minor allergies to iodine will also be excluded.

Design:

Number of Participants: 30

Recruitment Time Frame: approximately 2 years

Type of Study: Feasibility study

This is a pilot study to assess the characteristics of radio-opaque bland beads during TAE in the treatment of hepatic malignancies. Patients may also receive thermal ablation treatment in conjunction with TAE if clinically indicated, although comparison of bead treatment with or without thermal ablation is not part of the study s aim.

To compare virtual and actual perfusion characteristics of the LUMI radiopaque beads with CBCT and/or CT. Patients scans will be obtained per TAE standard of care schedule. Other imaging evaluation of this therapy may be performed at regular intervals following completion of treatment, and will be governed by standard conventional imaging regimen post treatment.

The choice of which combination of imaging (CT, Cone beam CT (CBCT), or fluoroscopy) and when to image, will be made by the clinical care team for the patient, based upon multidisciplinary recommendations and NIH Clinical Center customary use and standard of care, and will be purely clinical decisions (not research-related).

The participants will have a diagnosed hepatic malignancy, and be eligible to undergo transarterial embolization and thermal ablation under general anesthesia. The LC LUMI bead will be used in the transarterial embolization procedure.

Follow up will continue for 12 months from the time of initial treatment.

Patients will be evaluated in multidisciplinary GI medical oncology clinic and up to 30 patients will be enrolled to accrue 20 evaluable patients.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatic tumors bead embolization	LC Bead LUMI	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.
Hepatic tumors bead embolization	Transarterial embolization (TAE)	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.

Primary Outcome Measures

Name	Time	Method
Perfusion Characteristics of Imageable Beads Using Cone Beam CT	One year post procedure	Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion

Secondary Outcome Measures