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

MRI-Assisted high intensity focused ultrasound metastatic Liver Tumor Ablation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25843
Enrollment
10
Registered
2014-02-13
Start date
2014-03-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic liver tumors Levermetastasen

Interventions

(partial) Magnetic Resonance-guided High Intensity Focused Ultrasound ablation of one liver metastasis

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Correspondance of the ablated volumes on MR thermometry (obtained per-procedural), MR imaging (obtained post-procedural), and histopathology (obtained from resection specimen)

Secondary

MeasureTime frame
Safety (adverse events, liver function tests)

Contacts

Public ContactJ. Wijlemans

UMC Utrecht, afd. Radiologie Postbus 85500, 3508GA

J.Wijlemans@umcutrecht.nl088-7550055

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)