Status:
RECRUITING
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
Lead Sponsor:
Society of Interventional Oncology
Conditions:
Colorectal Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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 CRC 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 in the largest diameter
- 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.
- 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.
- ECOG performance status of 0-1.
- Platelet count \>50,000/mm3 (correctable allowed) within 30 days prior to study treatment.
Exclusion
- 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 an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a 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 (see diagrams with illustration of central ducts).
- Patient is currently pregnant or intends to become pregnant
Key Trial Info
Start Date :
January 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2027
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT05265169
Start Date
January 13 2023
End Date
December 10 2027
Last Update
January 17 2024
Active Locations (7)
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1
Miami Cancer Institute
Miami, Florida, United States, 33176
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030