Microwave ablation for colorectal liver metastases

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure

This study is testing if microwave ablation can effectively treat small colorectal liver tumors in people and help them live without cancer progression for at least two years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 275 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Society of Interventional Oncology (Academic / other)
• Locations: 7 sites (Miami, Florida and 6 other locations)
• Trial ID: NCT05265169 on ClinicalTrials.gov

What this trial studies

This international clinical trial aims to establish microwave ablation (MWA) as a preferred curative therapy for selected colorectal liver metastases (CLM) that can be effectively treated with sufficient margins. The study will enroll approximately 275 subjects with one to three CLMs, each measuring up to 2.5 cm, and will assess the effectiveness of MWA in achieving a local progression-free survival rate of at least 90% over two years. The procedure will involve creating a minimum ablation margin of 5.0 mm around the tumors, with confirmation of the ablation zone assessed through imaging. The trial will utilize FDA cleared or CE Marked MWA devices and will be conducted across multiple centers.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed colorectal cancer and up to three hepatic metastases, each measuring 2.5 cm or less.

Not a fit: Patients with colorectal liver metastases larger than 2.5 cm or those with extensive metastatic disease beyond the liver may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a minimally invasive treatment option that significantly improves local tumor control for patients with colorectal liver metastases.

How similar studies have performed: Previous studies have shown promising results with microwave ablation for liver tumors, suggesting that this approach may be effective, though this specific study's methodology is novel.

Eligibility criteria

Inclusion Criteria:

1. Patient must be at least 18 years old.
2. Patient has signed a written informed consent for the MWA and participation in the study.
3. Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).
4. Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
5. Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any lymph node ≤2.0 cm in the largest diameter
6. Ability to safely create an ablation zone (AZ) that completely covers the tumor with minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule) or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be included. For these tumors, the calculation of the margin will not apply to the area abutting the capsule or the vessel.
7. The target tumor(s) is/are visible by US and/or CT in a location where MWA is technically achievable and safe based on the proximity to adjacent structures. Protective maneuvers such as hydrodissection for organ mobilization are allowed and will be recorded.
8. ECOG performance status of 0-1.
9. Platelet count \>50,000/mm3 (correctable allowed) within 30 days prior to study treatment.

Exclusion Criteria:

1. Patient is unable to lie flat or has respiratory distress at rest.
2. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
3. Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast.
4. Patient has evidence of active systemic infection.
5. Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
6. Patient is currently participating in other experimental studies that could affect the primary endpoint.
7. Patient unable to receive general anesthesia or adequate analgesia and sedation.
8. Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts).
9. Patient is currently pregnant or intends to become pregnant

Where this trial is running

Miami, Florida and 6 other locations

• Miami Cancer Institute — Miami, Florida, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Medical College of WI — Milwaukee, Wisconsin, United States (Recruiting)
• National and Kapodistrian University of Athens (NKUA) — Athens, Greece (Recruiting)
• Amsterdam UMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE — Memorial Sloan Kettering Cancer Center
• Study coordinator: Research Manager

Conditions Colorectal Liver Metastases