Actively Recruiting
Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-17
50
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment. Currently, such methods are only utilized in isolation and the benefit of a combined and standardized procedure workflow is unknown. Therefore, our primary goal of this single-arm clinical trial is to investigate the technical efficacy of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins for the treatment of patients referred to ablation for the treatment of primary and secondary liver cancers.
CONDITIONS
Official Title
Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with up to 5 colorectal liver metastases measuring up to 5 cm referred to percutaneous ablation
- Ability to cover the tumor completely with at least a 5 mm ablation margin based on imaging
- Distance to central bile ducts greater than 1 cm
- Adequate kidney function with glomerular filtration rate over 40 and no severe allergy to iodine contrast media
- Ability to understand and willing to sign informed consent
- Age over 18 years
- Performance status between 0 and 2 (ECOG)
- Expected survival longer than 12 months
You will not qualify if you...
- Use of prior or concurrent local therapy at the target tumor(s)
- Active bacterial or fungal infection on the day of ablation
- Platelet count below 50,000/mm3
- INR greater than 1.5
- Uncorrectable blood clotting disorders
- Currently breastfeeding or pregnant
- Physical or psychological conditions preventing study participation
- ASA score of 4 or higher
- Any other local therapies at the target lesions
- Anatomical liver artery variations preventing use of CT hepatic arteriography imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bruno Odisio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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