Status:
COMPLETED
Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Image-Guided Surgery
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 supp...
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 embolizat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
March 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01818440
Start Date
March 21 2013
End Date
August 22 2018
Last Update
August 31 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892