Trials / Completed
CompletedNCT01612325
Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases
Radioactive Holmium Microspheres for the Treatment of Patients With Unresectable Liver Metastases; a Single Center, Interventional, Non-randomized, Phase II (HEPAR II) Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- UMC Utrecht · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Holmium-166 polylactic microspheres | Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy. |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2012-06-05
- Last updated
- 2015-08-27
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01612325. Inclusion in this directory is not an endorsement.