High-precision liver ablation technique for colorectal metastasis

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

This study tests a new, precise liver treatment for patients with colorectal cancer that aims to improve recovery and reduce complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05361551 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a high-precision liver ablation technique that combines stereotactic guidance, intra-arterial CT imaging, and software assessment to improve treatment outcomes for patients with colorectal liver metastasis. The study aims to evaluate the technical efficacy and local tumor progression-free survival (LTPFS) achieved through this method. It will also assess various secondary outcomes, including the impact of ablation margins on LTPFS, adverse events, liver function, and overall oncological outcomes. The trial focuses on ensuring adequate tumor coverage and minimizing complications during the ablation process.

Who should consider this trial

Good fit: Ideal candidates include patients with up to 5 colorectal liver metastases measuring up to 5 cm who are eligible for percutaneous ablation.

Not a fit: Patients with active infections, severe coagulopathy, or those who have undergone prior local therapy for the target tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and survival rates for patients with colorectal liver metastasis.

How similar studies have performed: While the combination of these techniques is novel, similar studies have shown promising results with high-precision ablation methods.

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.

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Bruno Odisio, MD — M.D. Anderson Cancer Center
• Study coordinator: Bruno Odisio, MD

Conditions Liver Ablation; Hepatic