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Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases

NCT01612325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-08-27

No results posted yet for this study

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

  • Liver Neoplasms

Interventions

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.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Bernard Zonnenberg, MD, PhD · UMCU Utrecht Netherlands

  • Martin Hendriks, MD, PhD · UMCU Utrecht, Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612325 on ClinicalTrials.gov