Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment
Condition: Image-Guided Surgery
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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
    

Intervention name(s): 3D Roadmap software; Fluoroscopy
Intervention type(s): Other; Other
Intervention description(s): 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.; Patients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Surgical Navigation; Liver; Cancer; Image-guided Therapy