Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02649868 |
| Other study ID # |
160049 |
| Secondary ID |
16-CC-0049 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 12, 2016 |
| Est. completion date |
December 2, 2023 |
Study information
| Verified date |
April 12, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
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