Actively Recruiting
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
Led by Society of Interventional Oncology · Updated on 2024-01-17
275
Participants Needed
7
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
Who Can Participate
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 hepatic metastases confirmed on imaging (e.g., CT or MRI).
- Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
- Patient may have up to 5 lesions in the lung (none larger than 2.0 cm) and/or any lymph node 2.0 cm or smaller in largest diameter.
- Ability to safely create an ablation zone that completely covers the tumor with a minimal margin of 5.0 mm; subcapsular or perivascular lesions within 10 mm of liver capsule or vessels larger than 3 mm may be included with adjusted margin calculation.
- Target tumors must be visible by ultrasound and/or CT in locations where MWA is technically achievable and safe; protective maneuvers such as hydrodissection are allowed and recorded.
- ECOG performance status of 0-1.
- Platelet count greater than 50,000/mm3 (correctable allowed) within 30 days prior to study treatment.
You will not qualify if you...
- Patient is unable to lie flat or has respiratory distress at rest.
- Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
- Patient has a history of allergic reaction to intravenous iodine that cannot be pre-medicated or prevents CT with IV contrast.
- Patient has evidence of active systemic infection.
- Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow-up.
- Patient is currently participating in other experimental studies that could affect the primary endpoint.
- Patient unable to receive general anesthesia or adequate analgesia and sedation.
- Tumor location less than 25 mm from hilum.
- Patient is currently pregnant or intends to become pregnant.
AI-Screening
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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
Research Team
R
Research Manager
CONTACT
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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