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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-03903 | Other Identifier | NCI-CTRP-Clinical Trial Reporting Registry |
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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.
Primary Objective:
To evaluate the technical efficacy and Local Tumor Progression-free survival [LTPFS] 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 with colorectal liver metastasis referred to percutaneous liver ablation.
Secondary Objectives:
To evaluate the impact of this high-precision liver ablation technique on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver ablation | Experimental | The ablation procedure will be performed in 1 day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver ablation | Procedure | Ablation needle placement An image-guidance device be used for planning of the procedure and for placement of the ablation needle |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire (EQ-5D-3L) | The scale is numbered from 0-100 (100 means the best health you can imagine. 0 means the worst health you can imagine) | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Odisio, MD | Contact | (713) 563-1066 | bcodisio@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Odisio, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37563313 | Derived | Paolucci I, Albuquerque Marques Silva J, Lin YM, Fellman BM, Jones KA, Tatsui CE, Weinberg JS, Ruiz J, Tan J, Brock KK, Bale R, Odisio BC. Study Protocol STEREOLAB: Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment. Cardiovasc Intervent Radiol. 2023 Dec;46(12):1748-1754. doi: 10.1007/s00270-023-03524-9. Epub 2023 Aug 10. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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