Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05361551

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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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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Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB) | DecenTrialz