Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure
Society of Interventional Oncology
Summary
To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
Description
In this prospective, multi-center, standard of care trial we propose to establish microwave ablation (MWA) as the preferred curative therapy for selected colorectal liver metastases (CLM) that can be ablated with sufficient margins. Our hypothesis is that MWA of CLM ≤ 2.5 cm with confirmation of ablation margin over 5 mm achieves definitive local tumor control (local cure) with minimal morbidity. This international study will enroll subjects with one to three CLMs (for a total of 330 tumors/approximately 275 subjects) eligible for local cure using MWA. Any FDA cleared or CE Marked MWA device…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Subcapsul…
Interventions
- DeviceMicrowave ablation
Microwave ablation of colorectal liver metastases (CLM)
Locations (7)
- Miami Cancer InstituteMiami, Florida
- Mayo ClinicRochester, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York
- MD Anderson Cancer CenterHouston, Texas
- Medical College of WIMilwaukee, Wisconsin
- National and Kapodistrian University of Athens (NKUA)Athens