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
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What this Trial Is About
Researchers are investigating a high-precision liver ablation technique for patients with primary and secondary liver cancers, specifically colorectal liver metastasis. This technique combines stereotactic guidance, CT imaging during hepatic arteriography, and computer-based software to assess ablation margins. The study aims to evaluate the technical effectiveness and local tumor progression-free survival of this combined method, addressing the need for accurate tumor boundary definition, probe placement, and margin assessment during ablation procedures.
The treatment involves a one-day percutaneous liver ablation procedure where an image-guidance device is used for planning and precise placement of the ablation needle within the tumor. This combined approach integrates multiple steps previously used separately, aiming to improve ablation accuracy. The study will focus on various outcomes including minimal ablation margins, adverse events, liver function, tissue properties, radiation exposure, and overall oncological results.
Participants will undergo assessments including quality of life evaluations using the EQ-5D-3L questionnaire throughout the study, averaging about one year. Researchers will monitor tumor response, adverse events, and other clinical measures to understand the treatment's impact. Safety and procedural times are also evaluated. The total participation duration covers the treatment day and follow-up assessments to track clinical outcomes and quality of life.
CONDITIONS
Brief Title
Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Patients with up to 5 colorectal liver metastases measuring up to 5 cm referred for percutaneous ablation
Ability to cover the target tumor completely with at least a 5 mm ablation margin per imaging
Distance from tumor to central bile ducts greater than 1 cm
Adequate kidney function (GFR greater than 40) and no severe allergy to iodine contrast media
Ability to understand and sign informed consent
Age 18 years or older
Performance status 0 to 2 (ECOG classification)
Expected survival longer than 12 months
You will not qualify if you...
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
Pregnant or breastfeeding
Physical or psychological conditions that impair study participation
ASA score of 4 or higher
Any other loco-regional therapies at the target lesion(s)
Liver arterial blood supply variations preventing use of CT hepatic arteriography imaging
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 day
Participants undergo imaging analysis using intra-arterial CT hepatic arteriography and computer-based software to assess ablation margins before the liver ablation procedure.
1 visit (in-person)
Treatment
Duration - 1 day
Participants receive stereotactic-guided percutaneous liver ablation with image-guided ablation needle placement and ablation confirmation.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 1 year
Participants are followed up to evaluate technical efficacy, local tumor progression-free survival, quality of life, liver function, and oncological outcomes for up to 1 year.