This is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Radioembolization with QuiremSpheres® under MR imaging
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Feasibility of MR imaged administration of holmium microspheres
Feasibility is defined as successful treatment under MRI in at least 4 of 6 patients. Unsuccessful treatment is defined as having to abort the procedure for safety reasons, judged by the interventional radiologist, and having to complete the administration of microspheres under X-ray guidance as in normal practice. Possible reasons for this are uncertainty about the location of the catheter, or luxation of the catheter as a result of transport to the MRI scanner.
Time frame: 1 month after inclusion
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Patients are followed up to 3 months after treatment, during which all adverse events are recorded.
Time frame: Up to 3 months after treatment
Tumor/non-tumor ratio on MR based dosimetry
MR based dosimetry is performed immediately after treatment, resulting in dose maps. The dose that the tumor received is divided over the dose that the rest of the liver received.
Time frame: 1 month after inclusion
Comparison of dosimetry in Gray between MR based and SPECT based dose maps
Voxel-based dosimetry will be performed, leading to dose-volume histograms with a dose value per voxel in Gray. Statistical testing will be done for differences between these data sets, i.e. the two different imaging modalities (MR based and SPECT based). It is expected that dose-volume histograms will be similar between the two modalities.
Time frame: 1 month after inclusion
Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria)
Time frame: 3 months after treatment
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