To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
The novel fractional administration device enable the administration of the microspheres in fractions determined by the user. For this study, 5 fractions of 20% will be administered and validated using MRI.
RadboudUMC
Nijmegen, Netherlands
Validation of a fractional administration device for holmium radioembolization
The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%.
Time frame: 3 months after treatment
Safety of a fractional administration device for holmium radioembolization
The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's
Time frame: 6 months after treatment
Accurate dosimetry based on MRI and SPECT imaging of holmium-166.
To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response
Time frame: 6 months after treatment
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