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

Completed · Phase 2

Conditions studied: Image-Guided Surgery

In brief

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.

Key facts

Study ID

NCT01818440

Run by

National Institutes of Health Clinical Center (CC)

People needed

28

Starts

2013-03-21

Expected to finish

2018-08-22

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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