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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Ablation; Hepatic
• Intervention / Treatment: Procedure: Liver ablation

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Odisio, MD; Phone Number: (713) 563-1066; Email: bcodisio@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Bruno Odisio, MD; Phone Number: 713-563-1066; Email: bcodisio@mdanderson.org
      • Principal Investigator: Bruno Odisio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
2. Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
3. Distance to central bile ducts > 1 cm;
4. Adequate glomerular filtration rate (GFR > 40) and no severe allergies to iodine contrast-media;
5. Ability to understand and the willingness to sign written informed consent;
6. Age > 18 years-old;
7. Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG]);
8. Expected survival > 12 months.

Exclusion Criteria:

1. Use of other prior or concomitant local therapy at the target tumor(s).
2. Active bacterial infection or fungal infection on the day of the ablation.
3. Platelet < 50,000/mm3.
4. INR > 1.5
5. Patients with uncorrectable coagulopathy.
6. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
7. Physical or psychological condition which would impair study participation.
8. ASA (American Society of Anesthesiologists) score of ≥ 4.
9. Any other loco-regional therapies at the target lesion(s).
10. Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liver ablation; The ablation procedure will be performed in 1 day	Procedure: Liver ablation; Ablation needle placement An image-guidance device be used for planning of the procedure and for placement of the ablation needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Bruno Odisio, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2022-0221; NCI-2022-03903 (Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No