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van CCT (UK)

van CCT (UK)

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

- candidate number16419
- NTR NumberNTR4473
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2014
- Secondary IDsNL45332.041.13  METC UMC Utrecht protocol 13-382
- Public TitleMRI-guided focused ultrasound (MR-HIFU) treatment of liver tumors
- Scientific TitleMRI-Assisted high intensity focused ultrasound metastatic Liver Tumor Ablation
- hypothesisAccurate MR-HIFU ablation of liver metastases is feasible
- Healt Condition(s) or Problem(s) studiedMetastatic liver tumors
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2016
- Target number of participants10
- Interventions(partial) Magnetic Resonance-guided High Intensity Focused Ultrasound ablation of one liver metastasis
- Primary outcomeCorrespondance of the ablated volumes on MR thermometry (obtained per-procedural), MR imaging (obtained post-procedural), and histopathology (obtained from resection specimen)
- Secondary outcomeSafety (adverse events, liver function tests)
- TimepointsTimepoint 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.
- Trial web site
- statusstopped
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Center for Translational Molecular Medicine (CTMM), Project VOLTA
- PublicationsFor 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.
- Brief summaryMR-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.
- Main changes (audit trail)
- RECORD13-feb-2014 - 22-mei-2016

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