Clinical trial NCT05361551: Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Official title: Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Ablation
Hepatic
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Questionnaire (EQ-5D-3L)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Bruno Odisio, MD
role: PRINCIPAL_INVESTIGATOR
References: