Featured products: QuiremScout™ Microspheres, QuiremSpheres™ Microspheres
To establish the safety and toxicity profile of 166Ho-radioembolization in patients with HCC.
This interventional non-randomized study showed an acceptable low rate of holmium-166 radioembolization-related serious toxicity (3 out of 31 patients; <10%) in patients with hepatocellular carcinoma.
Dr. Mark C. Burgmans, UMC Leiden, Belgium
Sites enrolling: Leiden UMC, Netherlands; Amsterdam Medical Centre
Patients: 20, early stage HCC
This is a dose-finding study, where patients receive Radiofrequency thermal ablation and adjuvant segmental Holmium-166 SIRT (QuiremSpheres®).
Purpose: Combining radiofrequency ablation with adjuvant Ho-166 SIRT in HCC patients (1-3 HCC lesions)
Primary objective: Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients. Holmium-6 SIRT, when
Local tumor recurrence at 6 months
Time to progression
Quality of Life
Expected Completion: 2021
The safety and efficacy of
166Holmium-SIRT in the treatment of liver metastases has been evaluated in HEPAR I (phase I) and HEPAR II (phase II) studies and retrospectively analysed to establish dose-response thresholds.
Phase I -Dose Escalation Study, recruited 15 patients with different liver metastases from various primary tumors (Ocular melanoma, colorectal cancer, cholangiocarcinoma, breast cancer)
Purpose: Primary endpoint: Determination of Maximum Tolerated Radiation Dose (MTRD)
MTRD was found to be 60 Gy
Disease control rate (PR+SD) in target lesions at 12 weeks was reported in 64% patients
Safety & efficacy evaluation of Holmium-166 SIRT
Phase II study in 37 patients with metastases from different primaries
23 of these patients had metastatic CRC
Primary Endpoint: Tumor Response at 3 months (RECIST 1.1)
Time to liver specific progression was 3 months
Median overall survival was 14.5 months
Median overall survival for mCRC patients was 13.4 months
Radioembolization with QuiremSpheres® is technically effective, with an acceptable toxicity profile in the salvage treatment of patients with liver metastases
Purpose: to evaluated the safety and technical efficacy of 166Holmium-SIRT as adjunct treatment after systemic
177Lu-dotatate in 30 patients with mNET. Prospective, single arm study.
Patients received 4 cycles of PRRT (peptide receptor radionuclide therapy)
Followed by QuiremSpheres® administration to achieve local radiation boost
The toxicity profile is comparable to literature, mainly grade 1-2 abdominal pain, fatigue and nausea.
The overall toxicity was low: CTCAE v 4.03 grade 3 - 4 with one fatal REILD, while the QoL recovered at 3 months.
The safety and performance of the use of
166Holmium as Scout Dose in comparison to 99mTc-MAA has been evaluated in different studies,6,7,8 concluding that:
250 MBq is safe to use prior to SIRT as an alternative to
99mTc-MAA with superior predictive value in estimating the lung shunt in patients with primary and secondary liver tumors7
QuiremScout® showed to be safe in all the patients with extrahepatic depositions7Publication
QuiremScout® could lead to more reliable pre-treatment imaging and subsequently to improved individualized treatment planning due to the identical morphology of the microspheres7
QuiremScout® is more accurate than the commonly used surrogate
99mTc-MAA in predicting lung shunting8 and intrahepatic distribution.7
Qualitative and quantitative analysis of the intrahepatic distribution demonstrated significant better agreement between
166Ho Scout and 166Ho treatment versus 99mTc-MAA.8
99mTc-MAA could lead to unnecessary patient exclusion from SIRT and/ or under-dosing of tumor due to overestimation of lung shunt and other off-target tissue embolization. 8Publication
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