NCT01818440

Brief Summary

Background: \- Researchers are interested in comparing two methods that doctors can use to position catheters in blood vessels. These methods are used to deliver chemotherapy and close the blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to help the doctor choose the best position for the catheter to get to the tumor. The computer shows the route on an x-ray screen in real time. This technique may help doctors position the catheter with less x-ray dye and in a shorter time. These methods will be compared in people who are having a procedure to destroy liver tumors. The procedure, called trans-arterial embolization, will deliver chemotherapy and destroy the tumor blood supply. Objectives: \- To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor treatment. Eligibility: \- Individuals at least 18 years of age who are having trans-arterial embolization for liver cancer. Design:

  • Participants will be screened with a physical exam and medical history. They will provide blood and urine samples, and have imaging studies.
  • Participants will be divided into two groups. One group will have regular fluoroscopy (X-ray) during the procedure. The other group will have the procedure with the 3-D Roadmap software.
  • In the first group, participants will have a CT scan. The doctor will decide how many vessels need to be treated. The doctor will advance the catheter using fluoroscopy only. Another CT scan will be given after the procedure.
  • In the second group, participants will have a CT scan. The doctor will look at the scan with the 3-D Roadmap software. The software will show the path to advance the catheter. The doctor will use the software to help destroy the tumors. Another CT scan will be given after the procedure.
  • Both groups will have the same follow-up care afterward. Other tests will be given as needed for the cancer treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

March 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2015

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 22, 2018

Enrollment Period

2.5 years

First QC Date

March 21, 2013

Last Update Submit

August 29, 2018

Conditions

Image-Guided Surgery

Keywords

Surgical NavigationLiverCancerImage-guided Therapy

Outcome Measures

Primary Outcomes (1)

  • To compare safety, efficacy, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures.

    2 years

Study Arms (2)

A

ACTIVE COMPARATOR

Patients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method

Other: Fluoroscopy

B

EXPERIMENTAL

Patients will have the procedure performed using the 3-D Roadmap software.With the 3DRoadmap, images from a Cone-Beam CT are analyzed. Software shows the vessels supplying the tumor and the plan is displayed on top of fluoroscopy

Other: 3D Roadmap software

Interventions

3D Roadmap softwareOTHER

Two scanning methods will be used by doctors to position catheters in the blood vessels to deliver the chemotherapy and close the blood supply to the tumor.

B
FluoroscopyOTHER

Patients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method.

A

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have primary or metastatic hepatic tumors scheduled for trans-arterial chemo-embolization or bland embolization in interventional radiology. A multi-disciplinary team including oncology, surgery, pathology and radiation oncology as well as interventional radiology will review each candidate and determine the eligibility for TACE or bland embolization and ineligibility for other interventions.
  • Age \>18 years
  • They must be eligible for trans-arterial chemoembolization or bland embolization

You may not qualify if:

  • Patients with an altered mental status precluding understanding or consenting for the procedure
  • History of allergic reactions to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids.
  • Pregnant women are excluded from the study because ionizing radiation is teratogenic or abortifacient effects. Patients are excluded from pregnancy testing if they are above the childbearing age of 55 years old, or if they have documented history of infertility or acquired or congenital disorders incompatible with pregnancy or if the patient has had a hysterectomy or bilateral oophorectomy. Patients are also excluded from pregnancy testing if they are at least 50 years of age AND have not menstruated for at least 12 months OR have a documented Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
  • Patients with a total body weight exceeding 375 pounds since that is the weight limit of the angiography table.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Meyer BC, Witschel M, Frericks BB, Voges M, Hopfenmuller W, Wolf KJ, Wacker FK. The value of combined soft-tissue and vessel visualisation before transarterial chemoembolisation of the liver using C-arm computed tomography. Eur Radiol. 2009 Sep;19(9):2302-9. doi: 10.1007/s00330-009-1410-x. Epub 2009 May 8.

    PMID: 19424701BACKGROUND

  • Li C, Heidt DG, Dalerba P, Burant CF, Zhang L, Adsay V, Wicha M, Clarke MF, Simeone DM. Identification of pancreatic cancer stem cells. Cancer Res. 2007 Feb 1;67(3):1030-7. doi: 10.1158/0008-5472.CAN-06-2030.

    PMID: 17283135BACKGROUND

  • Wallace MJ, Murthy R, Kamat PP, Moore T, Rao SH, Ensor J, Gupta S, Ahrar K, Madoff DC, McRae SE, Hicks ME. Impact of C-arm CT on hepatic arterial interventions for hepatic malignancies. J Vasc Interv Radiol. 2007 Dec;18(12):1500-7. doi: 10.1016/j.jvir.2007.07.021.

    PMID: 18057284BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Bradford J Wood, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 26, 2013

Study Start

March 21, 2013

Primary Completion

September 16, 2015

Study Completion

August 22, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08-22

Locations

US(1)