NCT05183776

Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT

Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Cancer
• Liver Metastasis Colon Cancer
• Primary Liver Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2022-01-11
• Last updated: 2023-11-18

Locations

1 site across 1 country: Netherlands