Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases
- Conditions
- Liver Neoplasms
- Interventions
- Device: Holmium-166 polylactic microspheres
- Registration Number
- NCT01612325
- Lead Sponsor
- UMC Utrecht
- Brief Summary
Radioembolisation is a known method for the treatment of liver tumors and or livermetastases. Currently small beadlets called microspheres are used that are loaded with the beta radiation emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics including good visualisation in gammacameras due to the gamma emission. Because of the higher specific activity higher radiation doses to the liver will be used compared to the standard Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved antitumor effect.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Holmium-166 MS radioembolization Holmium-166 polylactic microspheres Single radioembolization met Holmium-166 polylactic microspheres administered
- Primary Outcome Measures
Name Time Method Target lesions tumour response 3 month after treatment After the administration of the Ho-166 microspheres the size of the target lesions in the liver will be determined using RECIST 1.1 criteria using CT scan
- Secondary Outcome Measures
Name Time Method Toxicity according CTC v 4 criteria Clinical evaluation after 1,3,6,9,12,24,36,52 weeks Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52
Trial Locations
- Locations (1)
Department of Radiology University Medical Center Utrecht
🇳🇱Utrecht, Netherlands