Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) (ACCLAIM)

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Liver Metastases
• Intervention / Treatment: Device: Microwave ablation

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 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 will be acceptable for use. MWA will be performed with the intent to create a minimum margin of ablation of 5.0 mm and ideally ≥10 mm from the edge of the target tumor to the ablation periphery.

Minimum margin (MM) size will be documented intra-procedurally (immediately post MWA with contrast-enhanced CT) and again within 4-8 weeks after MWA. Assessment of the MM will be conducted by an independent core lab using an FDA approved/cleared image-processing software to provide 3D assessment of the ablation zone and margin.

• The initial assessment of the MM by the core lab will be conducted within 7 days of the MWA and again within 7 days after SOC imaging 4-8 weeks post MWA
• A minimal ablation margin of 5.0 mm will represent the necessary condition for technical success of the ablation.
• Margin assessment will be verified by an independent physician reviewer. For MMs less than 5 mm, repeat MWA will be performed whenever feasible/safe, within 30 days from detection, in order to achieve sufficient MM (> 5mm). Minimum margin size will be correlated with time to local tumor progression. Local disease-free progression (within or abutting the ablation zone) and hepatic disease-free survival (accounting for all tumors ablated) stratified by MM of ≥ 5.0-9.9 mm and ≥ 10.0 mm will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Manager; Phone Number: 202-367-1164; Email: ACCLAIM@SIO-central.org

Study Locations

• Greece
  • Athens, Greece, 12462
    • Recruiting
    • National and Kapodistrian University of Athens (NKUA)
    • Contact: Dimitrios K Filippiadis, MD, PhD; Email: dfilippiadis@med.uoa.gr
    • Principal Investigator: Dimitrios K Filippiadis, MD, PhD
• Netherlands
  • Amsterdam, Netherlands, 1081
    • Recruiting
    • Amsterdam UMC
    • Contact: Susan van der Lei, MD; Email: s.vanderlei@amsterdamumc.nl
    • Principal Investigator: Martijn Meijerink, MD, PhD
• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute
      • Principal Investigator: Govindarajan Narayanan, MD
      • Contact: Jenny Camus; Phone Number: 786-527-8151; Email: Juana.Camus@baptisthealth.net
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Grant Schmit, MD
      • Sub-Investigator: Anil Kurup, MD
      • Sub-Investigator: Matt Callstrom, MD, PhD
      • Contact: Desirae Howe-Clayton; Phone Number: 507-255-0111; Email: Howe.Desirae@mayo.edu
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Nadia Petree; Email: petree@mskcc.org
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Maria C Briones Dimayuga, MD; Phone Number: 832-792-1692; Email: mcbrione@mdanderson.org
      • Contact: Barom J Aromin, RN; Phone Number: 2817877562; Email: BJAromin@mdanderson.org
      • Principal Investigator: Bruno C Odisio, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of WI
      • Contact: Dawn Carini; Phone Number: 414-955-0212; Email: dcarini@mcw.edu
      • Principal Investigator: Amanda Smolock, MD
      • Sub-Investigator: William Rilling, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. 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.
7. 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.
8. ECOG performance status of 0-1.
9. Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study treatment.

Exclusion Criteria:

1. Patient is unable to lie flat or has respiratory distress at rest.
2. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
3. 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.
4. Patient has evidence of active systemic infection.
5. Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
6. Patient is currently participating in other experimental studies that could affect the primary endpoint.
7. Patient unable to receive general anesthesia or adequate analgesia and sedation.
8. Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts).
9. Patient is currently pregnant or intends to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave ablation with margin confirmation; 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; Microwave ablation of colorectal liver metastases (CLM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor progression free survival at 24 months	See Above	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic progression free survival by Kaplan-Meier estimate	See Above	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	See Above	24 Months
Progression free survival using Kaplan-Meier methodology and the log-rank test	See Above	24 Months
Overall and disease specific survival following MWA using Kaplan-Meier methodology	See Above	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	See Above	24 Months
Proportion of subjects with CTCAE grade 3 events or greater within 90 days after MWA	See Above	90 Days

Collaborators and Investigators

• Sponsor: Society of Interventional Oncology
• Investigators: Principal Investigator: Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): December 10, 2027

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: SIO-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes