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

Conditions

• Hepatic
• Liver Ablation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Liver ablation — PROCEDURE
  Ablation needle placement An image-guidance device be used for planning of the procedure and for placement of the ablation needle

Study Details

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.

Key Dates

Start date

Feb 21, 2023

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Liver ablation
  The ablation procedure will be performed in 1 day

Primary Outcome Measure

Quality of Life Questionnaire (EQ-5D-3L) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

• Bruno Odisio, MD
  (713) 563-1066
  [email protected]

Locations (1)

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