AI-Powered Research

- At least 18 years old;
- Able to give informed consent;
- One or more metastatic liver tumor(s);
- Target tumor is eligible for surgical resection;
- Sufficient physical condition to undergo general anesthesia or deep sedation;
- Waist circumference that allows positioning on the HIFU table-top inside the MR bore;
- Based on a clinically available CT/MRI scan, the liver tumor is potentially accessible for MR-HIFU treatment (this relies on the judgment of the investigator and physicians).

Exclusion Criteria

- Contra-indication for MRI scanning according to the hospital guidelines;
- Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast-agent, and renal failure (defined as GFR < 30mL/min/1.73m2);
- Patients who prefer not to be informed about unexpected MRI findings;
- Surgical clips or considerable scar tissue in the HIFU beam path;
- Past or future other loco regional therapies for the same tumor (that is to be treated with MR-HIFU ablation) until the moment of surgical resection, such as (but not restricted to) RF ablation, microwave ablation, cryoablation, chemo-embolization, radio-embolization, or radiotherapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this first-in-man study is to investigate the accuracy<br /><br>of MR-HIFU ablation of metastatic liver tumors. The accuracy is assessed by<br /><br>comparing: I) ablated tissue volume, visualized as non-perfused volume on<br /><br>contrast-enhanced MR imaging after HIFU treatment; II) thermal dose as measured<br /><br>by MR thermometry during treatment; III) the necrotic tissue volume in the<br /><br>surgical resection specimen. In addition, the quality of the ablated tissue<br /><br>volume will be assessed.<br /><br>Thus, complete tumor ablation is not required for this study; tumor size is<br /><br>therefore of lesser importance.</p><br>

Secondary Outcome Measures