Real-time 3D confirmation of complete ablation with margins as a local cure for colorectal liver metastases: the ACCLAIM trial.
Constantinos T Sofocleous, Matthew R Callstrom, Elena N Petre...
https://pubmed.ncbi.nlm.nih.gov/41013745Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05265169
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure
Led by Society of Interventional Oncology · Updated on 2024-01-17
275
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating microwave ablation (MWA) as a potential curative treatment for patients with up to three colorectal liver metastases (CLM), each measuring 2.5 cm or less. The study aims to show that MWA can achieve a local progression-free survival rate of at least 90% over two years. This international, prospective, multi-center trial focuses on establishing MWA as a preferred standard of care for selected liver metastases by ensuring adequate ablation margins. Participants will undergo MWA using any FDA cleared or CE marked device, targeting one to three liver metastases. The procedure aims to create an ablation zone with a minimum margin of 5.0 mm, ideally 10 mm, around each tumor to maximize local tumor control. Margin size will be measured immediately after ablation and again 4-8 weeks later using contrast-enhanced CT scans reviewed by an independent core lab with 3D imaging software. If margins less than 5 mm are found, repeat ablation may be performed within 30 days if safe. During the study, participants will be closely monitored with imaging and clinical assessments to evaluate local tumor progression and overall hepatic disease-free survival. Researchers will also track tumor coverage by the ablation zone and any serious adverse events within 90 days post-procedure. The primary outcome is local tumor progression-free survival at 24 months. Secondary outcomes include hepatic progression-free survival, overall survival, and safety measures. The total participation period aligns with these assessments over two years.
CONDITIONS
Brief Title
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient must be at least 18 years old.
- Patient has signed a written informed consent for the MWA and participation in the study.
- Patient with pathologically confirmed colorectal cancer with liver metastases confirmed on imaging.
- Patient has up to 3 liver metastases, each up to 2.5 cm in largest diameter.
- Patient may have up to 5 lung lesions (none larger than 2.0 cm) and/or lymph nodes 2.0 cm or smaller.
- Ability to safely create an ablation zone completely covering the tumor with a minimum margin of 5.0 mm.
- Target tumors must be visible by ultrasound or CT and in a location where MWA is technically safe.
- ECOG performance status of 0-1.
- Platelet count greater than 50,000/mm3 (correctable allowed) within 30 days before treatment.
You will not qualify if you...
- Unable to lie flat or has respiratory distress at rest.
- Uncontrolled or uncorrectable bleeding disorders.
- History of allergic reaction to intravenous iodine preventing CT with contrast.
- Evidence of active systemic infection.
- Debilitating medical or psychiatric illness preventing consent or treatment.
- Currently participating in other experimental studies affecting the primary endpoint.
- Unable to receive general anesthesia or adequate sedation.
- Tumor located less than 25 mm from the liver hilum.
- Currently pregnant or intending to become pregnant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single procedure with follow-up imaging within 4 to 8 weeks
Participants undergo microwave ablation of 1 to 3 colorectal liver metastases using an FDA cleared or CE Marked device to create a minimum ablation margin of 5.0 mm.
1 ablation procedure visit and 2 imaging visits within 8 weeks post-procedure
Post-operative Follow-up
Duration - Up to 90 days
Participants are monitored for ablation margin assessment, potential repeat ablation if margins are insufficient, and for safety events up to 90 days after ablation.
Approximately 3 follow-up visits within 90 days
Long-term Monitoring
Duration - Up to 24 months
Participants are followed for local tumor progression, hepatic disease-free survival, and overall survival up to 24 months after treatment.
Periodic visits for assessments during 24 months
Trial Site Locations
Total: 7 locations
1
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Medical College of WI
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
6
National and Kapodistrian University of Athens (NKUA)
Athens, Greece, 12462
Actively Recruiting
7
Amsterdam UMC
Amsterdam, Netherlands, 1081
Actively Recruiting
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Research Team
R
Research Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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