RECRUITING

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-13

Study Completion:2027-12-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05265169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Research Manager

CONTACT

202-367-1164

ACCLAIM@SIO-central.org

Principal Investigator

Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Miami Cancer Institute

Miami, Florida, 33176

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Medical College of WI

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Society of Interventional Oncology

Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-13

Study Completion Date2027-12-10

Study Record Updates

Study Start Date2023-01-13

Study Completion Date2027-12-10

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Liver Metastases