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New treatment option for Colorectal Liver Metastases
Official title Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
ClinicalTrials.gov ID: NCT05265169
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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...
- ECOG performance status of 0-1.
- Platelet count \>50,000/mm3 (correctable allowed) within 30 days prior to study treatment.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
- Athens, Greece
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Rochester, Minnesota, United States; New York, New York, United States; Houston, Texas, United States; Milwaukee, Wisconsin, United States; Athens, Greece and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.