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Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment

NCT01818440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-08-31

No results posted yet for this study

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.

Conditions

  • Image-Guided Surgery

Interventions

OTHER

3D Roadmap software

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.

OTHER

Fluoroscopy

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

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Bradford J Wood, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-21
Primary Completion
2015-09-16
Completion
2018-08-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818440 on ClinicalTrials.gov