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History of Changes for Study: NCT02649868
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
Latest version (submitted October 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 7, 2016 None (earliest Version on record)
2 January 8, 2016 Study Description, Study Status and Study Identification
3 January 13, 2016 Eligibility and Study Status
4 May 11, 2016 Study Status
5 August 6, 2016 Eligibility and Study Status
6 August 31, 2016 References and Study Status
7 December 21, 2016 Study Status
8 December 23, 2016 Study Status
9 January 19, 2017 Study Status
10 January 20, 2017 Study Status
11 January 24, 2017 Study Status
12 April 20, 2017 Study Status and Study Design
13 May 12, 2017 Study Design and Study Status
14 June 30, 2017 Study Status
15 October 18, 2017 Study Status
16 December 1, 2017 Study Status and Outcome Measures
17 December 6, 2017 Study Status
18 March 27, 2018 Contacts/Locations and Study Status
19 May 9, 2018 Contacts/Locations and Study Status
20 August 8, 2018 Oversight and Study Status
21 November 8, 2018 Recruitment Status, Study Status, Contacts/Locations, Study Design, Eligibility, Study Description and Oversight
22 November 9, 2018 Study Status
23 January 10, 2019 Study Status
24 September 11, 2019 Study Status
25 September 24, 2019 Study Status
26 November 14, 2019 Study Status and Eligibility
27 November 15, 2019 Study Design and Study Status
28 November 19, 2019 Study Status
29 June 19, 2020 Oversight and Study Status
30 September 22, 2020 Study Status
31 October 27, 2020 Study Status
32 November 5, 2020 Study Status
33 July 13, 2021 Study Design and Study Status
34 August 19, 2021 Eligibility, Outcome Measures, Study Description, Oversight and Study Status
35 August 20, 2021 Study Status and Eligibility
36 September 1, 2021 Arms and Interventions and Study Status
37 October 8, 2021 Study Status
38 November 17, 2021 Arms and Interventions, Oversight and Study Status
39 November 19, 2021 Study Status
40 March 15, 2022 IPDSharing and Study Status
41 March 16, 2022 Study Status
42 March 17, 2022 Study Status
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111 July 1, 2022 Study Status
112 July 5, 2022 Study Status
113 July 6, 2022 Study Status
114 July 8, 2022 Study Status
115 September 7, 2022 Contacts/Locations and Study Status
116 October 4, 2022 Study Status
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Study NCT02649868
Submitted Date:  January 7, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 160049
Brief 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
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
Secondary IDs: 16-CC-0049
Open or close this module Study Status
Record Verification: December 2015
Overall Status: Recruiting
Study Start: January 2016
Primary Completion: December 2017 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: January 7, 2016
First Submitted that
Met QC Criteria:
January 7, 2016
First Posted: January 8, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 7, 2016
Last Update Posted: January 8, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institutes of Health Clinical Center (CC)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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

Objectives:

-To determine the imaging characteristics of radiopaque beads in the treatment of hepatic tumors using bead embolization.

Eligibility:

  • At least greater than or equal to 18 years of age
  • Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE with beads
  • ECOG performance status less than or equal to 2
  • Patients must have normal organ and marrow function per laboratory parameters
  • Patients with minor allergies to iodine will also be excluded, all other non-iodine-related exclusion criteria are standard of care exclusion criteria for TAE

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.
  • 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, 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.
  • Study period is 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 over 1 year to accrue 20 evaluable patients.
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 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 LUMI are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Objectives:

-To determine the imaging characteristics of radiopaque beads in the treatment of hepatic tumors using bead embolization.

Eligibility:

  • At least greater than or equal to 18 years of age
  • Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE with beads
  • ECOG performance status less than or equal to 2
  • Patients must have normal organ and marrow function per laboratory parameters
  • Patients with minor allergies to iodine will also be excluded, all other non-iodine-related exclusion criteria are standard of care exclusion criteria for TAE

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.
  • 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, 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.
  • Study period is 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 over 1 year to accrue 20 evaluable patients.
Open or close this module Conditions
Conditions: Hepatic Cancer
Liver Neoplasms
Hepatocellular Cancer
Liver Cancer
Keywords: Radio-Opaque Bland Beads
Thermal Ablation
Transarterial Embolization
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
Treatment of hepatic tumors using bead embolization.
Radiation: 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To determine the imaging characteristics of radiopaque beads in the treatment of hepatic tumors using bead embolization.
[ Time Frame: 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 84 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:
  • 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.
  • Age < 85 years
  • Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy within 28 days prior to initial treatment and must have recovered from all clinically significant side effects of therapeutic and diagnostic interventions. Anti- VEGF or antivascular or antiangiogenic agents (e.g., Avastin, lapatinib (Tykerb), sunitinib (Sutent), sorafenib (Nexavar), Axitinib, Pazopanib) may not be administered less than 30 days prior to embolization treatment.
  • 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
  • Prior 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.
Open or close this module Contacts/Locations
Central Contact Person: Charisse Garcia, R.N.
Telephone: (301) 594-4511
Email: garciacr@mail.nih.gov
Study Officials: Bradford Wood, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Locations: United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 Ext. TTY8664111010 prpl@mail.cc.nih.gov
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: NIH Clinical Center Detailed Web Page
Available IPD/Information:

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