This clinical trial studies how well image-guided liver ablation procedure works in improving treatment accuracy and effectiveness in patients with colorectal cancer that has spread to the liver (liver metastases). The current standard for targeting tumor cells and testing the outcome of a liver ablation procedure (in which tumor cells are destroyed using microwave or radiofrequency ablation) is mainly a visual approach. Thus, targeting of the tumor is done visually under computed tomography (CT) image-guidance and complete coverage of the tumor is then checked using a visual inspection of pre- and post-procedure CT scans. This study may help researchers learn if the combined use of various software and imaging tools can help to improve the accuracy and effectiveness of liver ablation. So far, these technologies have been studied mostly independently and researchers want to combine them to a high-precision ablation procedure.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05361551.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Bruno Calazans Odisio
Phone: 713-563-1066
PRIMARY OBJECTIVE:
I. To evaluate the technical efficacy and local tumor progression-free survival (LTPFS) of a high-precision liver ablation technique comprised by stereotactic-guidance, computed tomography (CT) during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins, for the treatment of patients with colorectal liver metastasis referred to percutaneous liver ablation.
SECONDARY OBJECTIVES:
I. To evaluate the impact of this high-precision liver ablation technique on:
Ia. Impact of minimally ablated margins on LTPFS.
Ib. Three-dimensional (3D) Minimal ablation margins.
Ic. Adverse events.
Id. Liver function.
Ie. Tissue properties from ultrasound (US) elastography.
If. Contrast-media utilization and radiation exposure.
Ig. Overall oncological outcomes (disease-free and overall survival, and ability to provide salvage local therapy at the time of recurrence).
Ih. Anesthesia/procedural time.
Ii. Response and duration of response.
Ij. Assessing whether ringenhancing hypervascular liver micronodules represent metastasis
OUTLINE:
Patients undergo intra-arterial CT hepatic arteriography (CTHA) during standard of care (SOC) percutaneous thermal ablation procedure. During SOC percutaneous thermal ablation procedure, stereotactic guidance is used to accurately place ablation needles. Computer software is also used to assess surgical margins and repeat ablation procedure if needed.
After completion of study intervention, patients are followed up at 1, 3, and 6 months, and 1 and 2 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBruno Calazans Odisio
