Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)


About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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

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

9. Patient is currently pregnant or intends to become pregnant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/25/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grant Schmit, M.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Desirae Howe-Clayton

(507) 255-0111


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