No registrations found.
ID
Source
Brief title
Health condition
Metastatic liver tumors
Levermetastasen
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correspondance of the ablated volumes on MR thermometry (obtained per-procedural), MR imaging (obtained post-procedural), and histopathology (obtained from resection specimen)
Secondary outcome
Safety (adverse events, liver function tests)
Background summary
MR-HIFU allows for completely non-invasive tumor ablation (desctruction with heat) under real-time imaging and temperature guidance. In this treat-and-resect study, patients with a liver metastasis will first receive an MRI scan. This allows the researchers to determine if the MR-HIFU treatment is possible. If so, the patient will be treated with MR-HIFU before undergoing standard surgical removal of the tumor. Blood samples will be obtained to study the biochemical effect on the liver. The resected tumor will be analyzed to study the effect of the MR-HIFU treatment on the tumor.
Study objective
Accurate MR-HIFU ablation of liver metastases is feasible
Study design
Timepoint 1: pre-treatment MRI
Timepoint 2: MR-HIFU procedure
Note: surgical resection of the targeted tumor (standard clinical care) will follow 1-4 weeks after the MR-HIFU procedure. The resection specimen will be used for comparison with the MR thermometry and imaging data.
Intervention
(partial) Magnetic Resonance-guided High Intensity Focused Ultrasound ablation of one liver metastasis
Postbus 85500, 3508GA
J. Wijlemans
Heidelberglaan 100
Utrecht 3584CX
The Netherlands
088-7550055
J.Wijlemans@umcutrecht.nl
Postbus 85500, 3508GA
J. Wijlemans
Heidelberglaan 100
Utrecht 3584CX
The Netherlands
088-7550055
J.Wijlemans@umcutrecht.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4324 |
| NTR-old | NTR4473 |
| CCMO | NL45332.041.13 |
| OMON | NL-OMON41228 |