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

Tracking Information

• First Submitted Date: January 7, 2016
• First Posted Date: January 8, 2016
• Last Update Posted Date: July 11, 2022
• Actual Study Start Date: January 12, 2016
• Estimated Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2021)

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.

• Original Primary Outcome Measures (submitted: January 7, 2016): To determine the imaging characteristics of radiopaque beads in the treatment of hepatic tumors using bead embolization. [ Time Frame: 2 years ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• 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

Study Arms

• Experimental: 1
  Treatment of hepatic tumors using bead embolization.
  Interventions:

  • Procedure: TAE
  • Radiation: RFA
  • Device: LC Bead LUMI
• Experimental: 2
  Treatment of hepatic tumors using bead embolization
  Interventions:

  • Procedure: TAE
  • Device: LC Bead LUMI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: January 7, 2016): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2023
• Estimated Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02649868
• Other Study ID Numbers: 160049; 16-CC-0049
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: .not yet known if there will be a plan to make IPD available

• Current Responsible Party: National Institutes of Health Clinical Center (CC)
• Original Responsible Party: Same as current
• Current Study Sponsor: National Institutes of Health Clinical Center (CC)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bradford J Wood, M.D.; National Institutes of Health Clinical Center (CC)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: July 5, 2022