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
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/13/2019 |
| Start Date: | January 12, 2016 |
| End Date: | December 15, 2020 |
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
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.
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.
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 LUMI , 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 greater than or equal to18 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: 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.
- 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 LUMI , 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 greater than or equal to18 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: 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.
- INCLUSION CRITERIA:
- 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 greater than or equal to18 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 (Karnofsky >60%).
- Patients must have normal organ and marrow function.
- Ability of subject to understand and the willingness to sign a written informed
consent document.
- Women of childbearing potential 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.
EXCLUSION CRITERIA:
- No contraindications to receive iodine products.
- Main Portal Vein Occlusion or other contraindications to chemoembolization
- Selective internal radiation therapy (SIRT) with 90-Y of more than one treatment per
lobe or a single whole liver treatment.
- Patients taking immunosuppressive drugs or unable to come off of ongoing chronic
anticoagulation will not be eligible.
- Patients with active bacterial infections with systemic manifestations (malaise,
fever, leukocytosis) are not eligible until completion of appropriate therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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