This phase II trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. The current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (CT) scans. Software-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation.
Additional locations may be listed on ClinicalTrials.gov for NCT04083378.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Bruno Calazans Odisio
Phone: 713-563-1066
PRIMARY OBJECTIVE:
I. To evaluate if the intra-procedure feedback of a biomechanical deformable registration volumetric image method during percutaneous ablation will increase the minimal ablation margins on a three-dimensional computed tomography-generated analysis.
SECONDARY OBJECTIVES:
I. To assess whether applying the proposed method during percutaneous ablation improves local tumor progression-free survival (LTPFS) rates.
II. Evaluate impact of software use on procedure workflow.
III. Impact of software use on complication rates, quality of life, liver function.
IV. Evaluate oncological outcomes (intra-hepatic and overall progression-free survivals, and overall survival).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care ablation.
ARM II: Patients undergo standard of care ablation with software-aided imaging (Morfeus) method.
After completion of study, patients are followed up at 45 days, 3 and 6 months, and then at 1 and 2 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBruno Calazans Odisio
