Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
Study NCT ID:
NCT05361551
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2022-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
1. Impact of minimally ablated margins on LTPFS
2. 3D Minimal ablation margins;
3. Adverse events;
4. Liver function;
5. Tissue properties from US elastography;
6. Contrast-media utilization and radiation exposure;
7. Overall oncological outcomes (disease-free and overall survival, and ability to provide salvage local therapy at the time of recurrence).
8. Anesthesia/procedural time
9. Response and Duration of response
10. Assessing whether ringenhancing hypervascular liver micronodules represent metastasis
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:
1. Impact of minimally ablated margins on LTPFS
2. 3D Minimal ablation margins;
3. Adverse events;
4. Liver function;
5. Tissue properties from US elastography;
6. Contrast-media utilization and radiation exposure;
7. Overall oncological outcomes (disease-free and overall survival, and ability to provide salvage local therapy at the time of recurrence).
8. Anesthesia/procedural time
9. Response and Duration of response
10. Assessing whether ringenhancing hypervascular liver micronodules represent metastasis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-03903 | OTHER | NCI-CTRP-Clinical Trial Reporting Registry | View |