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QuiremSpheres®

Microspheres

Description

Advancing the future of SIRT

QuiremSpheres® is based on Holmium-166 microspheres, which were developed in the clinic as an alternative to Yttrium-90 microspheres for treating unresectable liver tumors with selective internal radiation therapy (SIRT). Holmium-166 microspheres can be imaged with SPECT and MR, with high sensitivity and resolution, respectively. This makes it possible to perform post-treatment quantitative verification of the achieved dose distribution, i.e. determining dose-to-tumor and dose-to-tissue. With QuiremSpheres® you treat what you see and see what you treat.


Q-Suite™ - dosimetry software to confirm delivered radiation dose after Holmium-166 SIRT

Q-Suite™ allows you to perform accurate post-treatment dosimetry of Holmium-166 SIRT. With Q-Suite™, you can evaluate dose absorption at a voxel level based on SPECT/CT or MR imaging and generate a comprehensive dosimetry report per patient.

Characteristics

  • QuiremSpheres® has been shown in clinical trials to be safe1,2 and efficacious2 for the treatment of unresectable liver cancer
  • QuiremSpheres® is shipped in a ready-to-use patient-specific vial. There is no need for patient-dose preparation on-site.
  • QuiremSpheres® can be visualized with high accuracy (MRI) and high sensitivity (SPECT) after the treatment to verify dose delivery
  • QuiremSpheres® comes with Q-Suite dosimetry software, tailored for evaluating 166Ho SIRT.
  • We offer you an extensive QuiremSpheres® training program, including proctoring by a SIRT clinical expert, to ensure a seamless first treatment experience

Q-Suite™

  • Post-treatment Dosimetry: High resolution MRI; high accuracy SPECT
  • Voxel-wise dose calculation: Dose-point kernel, convolution method 
  • Fusion: Measure dose to tissue using CT or MR 
  • Integrated reporting: Export key data in a PDF report
  • Easy-to-use: Intuitive workflow based user interface

Preparation

Video instructions

 

Clinical evidence

Holmium-166 Radioembolisation in Patients with Unresectable, Chemorefractory Liver Metastases (HEPAR trial): A phase 1, Dose-Escalation Study

View study
Effi cacy of Radioembolisation with 166 Ho-Microspheres in Salvage Patients with Liver Metastases: A Phase 2 Study

View study
Holmium-166 Radioembolisation in Hepatocellular Carcinoma: Feasibility and Safety of a New Treatment Option in Clinical Practice

View study
See all clinical evidence

General specifications

​QuiremSpheres® is supplied as a standard dose in a single capped V-vial or as a standard dose divided among several capped V-vials.

​Characteristics
QuiremSpheres®Other SIRT products
IsotopeHolmium-166​Yt-90
Beta-radiation (Emax)1.77 MeV (48.7%)
1.85 MeV (50.0%)
2.28 MeV
Gamma-radiation81 keV (6.7%)-
Visible on MRIYesNo
Half-life26.8 hours64.1 hours
MaterialPoly(L-lactic acid)Resin (r) or glass (g)
Diameter15-60 μm20-60 μm (r) 
20-30 μm (g)
Density1.4 g/cm31.6 g/cm3 (r) 
3.3 g/cm3 (g)


Q-Suite™ version 1.2
​Software Requirements
​Hardware Recommendations
  • ​x64 based computer running Microsoft Windows 7, 8.1 or 10
  • Microsoft .NET version 4.5.2 framework should be installed
  • ​Dual-core CPU, 2.0GHz or higher
  • 16 GB RAM
  • SSD with 20 GB free disk space

Item specifications

Item reference
​Material description
​Description
​QS-V001​Holmium-166 microspheres,QuiremSpheres®
​V-vial containing a patient-specific dose of QuiremSpheres®
QS-C001​Customer kit
​Set of re-usable administration box and accessories for administration of QuiremSpheres®
QS-D001​Delivery setSet of sterile single-use tube lines for administration of QuiremSpheres® (in a carton of 6 pieces)​

​Item reference
​Material description
​Description
​8QSQ001
​Q-Suite™
​Holmium 166 SIRT post-treatment verification software


​QuiremSpheres® is a product manufactured by Quirem Medical B.V. and has CE-mark.

QuiremSpheres® is not available for sale in all countries. This information is provided only in respect to markets where the product is approved or cleared. QuiremSpheres® is not FDA cleared in the US for sale.

QuiremSpheres® is not approved in Canada

References

1 HEPAR I: Smits et al, 2012 Lancet Oncology 
2 HEPAR II: Prince et al, 2017 Journal of Nuclear Medicine

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