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

NCT05361551 | Recruiting

• 2 other identifiers: 2022-0221NCI-2022-03903
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Ablation; Hepatic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Liver ablation

EXPERIMENTAL

The ablation procedure will be performed in 1 day

Procedure: Liver ablation

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

Liver ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37563313 DERIVED

Related Links

• M D Anderson Cancer Center

Study Officials

• Bruno Odisio, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Odisio, MD

CONTACT

(713) 563-1066; bcodisio@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: February 21, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)