MRI-guided focused ultrasound (MR-HIFU) treatment of liver tumors

Suspended

Conditions: Metastatic liver tumorsLevermetastasen

Registration Number: NL-OMON25843

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: For an introduction, please refer to: Wijlemans JW, Bartels LW, Deckers R, Ries M, Mali WP, Moonen CT, Van den Bosch MA. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) ablation of liver tumours. Cancer Imaging. 2012 Sep 28;12:387-94.

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

- Contra-indication for MRI scanning
- 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
Correspondance of the ablated volumes on MR thermometry (obtained per-procedural), MR imaging (obtained post-procedural), and histopathology (obtained from resection specimen)

Secondary Outcome Measures