Completed

Prospective Randomized Trial Comparing Navigation With 3D Roadmap vs. Conventional Angiography During Transarterial Embolization

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What is being tested

Fluoroscopy

+ 3D Roadmap software

Other
Who is being recruted

Neoplasms

From 18 to 99 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: August 31, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: March 21, 2013

Actual date on which the first participant was enrolled.

Background: This is a phase II prospective randomized trial comparing novel tumor segmentation and navigation with 3D roadmap vs. conventional imaging with angiography during trans-arterial embolization procedures. Cone beam CT (CBCT) obtains CT-like images in the angiography suite during trans-arterial chemoembolization procedures and liver chemo-perfusion (PHP). In addition, 2D liver perfusion metrics can be calculated from angiography images. 3D Roadmap is a navigation tool/ software that utilize the data from the CBCT overlaid on live fluoroscopy to display a segmented tumor, delineate its vascular supply and to navigate catheters to the target vessels. Moreover, with 3D Roadmap, CBCT can be fused to prior CT or MRI for improved target visualization. The 3D Roadmap software received 510 (k) clearance on February 19, 2004. Our CRADA partner, Philips Healthcare, also submitted and received a separate 510 (k) clearance on January 30, 2015 for the software s vessel segmentation functionality and is under the trade name Emboguide. 3D Roadmap/ Emboguide software is intended to be used in combination with the AlluraClarity X-ray system. Primary Objective: To compare safety, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures. Eligibility: Subjects are eligible if: They are more than 18 years of age They have primary or metastatic hepatic tumors scheduled for trans-arterial chemo- embolization or bland embolization in interventional radiology They are eligible for trans-arterial chemoembolization or bland embolization Subjects are excluded if they have: An altered mental status precluding understanding or consenting for the procedure Contra-indications to trans-arterial embolization A gross body weight exceeding 375 pounds (upper limit of angio table) A pregnancy A severe allergic reaction to iodine contrast which cannot be controlled by premedication with antihistamines and steroids Design: Number of Participants: 30 Recruitment Time Frame: 2 years Number of sites: 1 Type of Study: prospective randomized clinical trial

NCT01818440
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: August 31, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

4 exclusion criteria prevent from participating
History of allergic reactions to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids
Patients with a total body weight exceeding 375 pounds since that is the weight limit of the angiography table
Patients with an altered mental status precluding understanding or consenting for the procedure
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center