An interventional study of Fractional administration device in Liver Cancer, Liver Metastasis Colon Cancer and Primary Liver Cancer, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 5 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
study patients will receive holmium radioembolization using a novel administration device.
Device: Fractional administration device
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.
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
Plan to share: No — Participant data will be available upon reasonable request
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center