Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

NCT05265169 | Recruiting FDA Device

• 1 other identifier: SIO-2021-01
• Study Type: interventional
• Target: 275
• Locations: 3 countries
• Sites: 7

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 standard of care (SOC) study.

Conditions

Colorectal Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Local tumor progression free survival at 24 months

  See Above

  24 Months

Secondary Outcomes (6)

• Hepatic progression free survival by Kaplan-Meier estimate

  24 Months

• Local tumor progression free survival between sufficient (5.0-9.9 mm) and ideal (≥10 mm) ablation margin categories using Kaplan-Meier methodology and the log-rank test

  24 Months

• Progression free survival using Kaplan-Meier methodology and the log-rank test

  24 Months

• Overall and disease specific survival following MWA using Kaplan-Meier methodology

  24 Months

• Proportion of target tumors treated with an ablation zone (AZ) that completely covers the target tumor(s) with minimal margin (MM) of at least 5 mm

  24 Months

Study Arms (1)

Microwave ablation with margin confirmation

EXPERIMENTAL

Patients who meet the eligibility criteria will undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with any FDA cleared/CE Marked Microwave Ablation System in accordance with the study site's standard-of-care (SOC) practices.

Device: Microwave ablation

Interventions

Microwave ablation DEVICE

Microwave ablation of colorectal liver metastases (CLM)

Microwave ablation with margin confirmation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Society of Interventional Oncology: lead

Study Sites (7)

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Medical College of WI

Milwaukee, Wisconsin, 53226, United States

RECRUITING

National and Kapodistrian University of Athens (NKUA)

Athens, 12462, Greece

RECRUITING

Amsterdam UMC

Amsterdam, 1081, Netherlands

RECRUITING

Related Publications (1)

• Sofocleous CT, Callstrom MR, Petre EN, Gonen M, Rilling WS, Ahmed M, Kelekis A, Soulen MC, Pereira P, Crocetti L, Dupuy DE, Solbiati L. Real-time 3D confirmation of complete ablation with margins as a local cure for colorectal liver metastases: the ACCLAIM trial. Trials. 2025 Sep 26;26(1):360. doi: 10.1186/s13063-025-09006-2.

  PMID: 41013745 DERIVED

Study Officials

• Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Manager

CONTACT

202-367-1164; ACCLAIM@SIO-central.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open-label multicenter trial

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: January 13, 2023
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); US (5); NL (1)