QuiremSpheres® microspheres are based on more than 15 years of research and development and we are continuously expanding our clinical evidence base. Clinical studies

HEPAR 2

Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases

 

Key findings:

• Radioembolization with holmium-166 microspheres was efficacious; in 73% of the patients the target lesions showed disease control after 3 months.

• Most common adverse events were transient abdominal pain and nausea (18% and 8%).

• Holmium-166 microspheres could be quantified with high accuracy and precision using SPECT.

 

Study design:

Single-arm, single-center phase II efficacy trial.

 

Patient population:

38 Patients with unresectable liver metastases of any primary origin, who were unable to undergo systemic treatment were eligible. The main primary malignancies were colorectal (61%), breast (11%), cholangiocarcinoma (11%), neuroendocrine tumor (5%) and uveal melanoma (5%).

 

Treatment:

Single radioembolization with Holmium-166 polylactic microspheres, administered via the hepatic artery. The projected average absorbed dose was 60 Gy to the liver (equal to 3.8 GBq/kg liver tissue).

 

Publications:

Study results have been published in PhD thesis of J.F. Prince; ISBN 978-90-393-6489-5; 2016.

Publication in peer-reviewed journal is expected soon.

ClinicalTrials.gov Identifier: NCT01612325

 

 

HEPAR 1

Holmium-166 radioembolization in patients with unresectable, chemorefractory liver metastases

 

Key findings:

• Holmium-166 radioembolization is considered feasible and safe.

• Toxicity after holmium-166 radioembolization was mainly confined to symptoms associated with post-embolisation syndrome; including fatigue, nausea, vomiting, abdominal pain, fever, and anorexia.

• The Maximum Tolerated Radiation Dose was identified to be an aimed whole liver average absorbed dose of 60 Gy.

• The distribution of holmium-166 microspheres can be visualized in vivo by both single-photon-emission CT (SPECT) and MRI, possibly enabling individualized and improved patient treatment in the future.

 

Study design:

Single-arm, single-center phase I dose-escalation trial.

 

Patient population:

15 Patients with unresectable, chemo refractory liver metastases were treated in cohorts of 3 patients. The primary tumour types were ocular melanoma (6/15), colorectal carcinoma (6/15), cholangiocarcinoma involvement (2/15), and breast carcinoma (1/15).

 

Treatment:

Single radioembolization with holmium-166 polylactic microspheres, administered by infusion in the liver artery using an arterial catheter in the femoral artery. Aimed whole-liver absorbed doses for consecutive dose cohorts were 20 Gy (n=6), 40 Gy (n=3), 60 Gy (n=3), and 80 Gy (n=3).

 

Publications:

Smits et al, Journal of Experimental & Clinical Cancer Research 2010, 29:70

Smits et al, Lancet Oncol. 2012, Oct;13(10):1025-34

ClinicalTrials.gov Identifier: NCT01031784

 

 

Ongoing clinical studies

 

Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization (SIM)

Phase II/III

25 Patients with unresectable, chemorefractory, liver-dominant colorectal liver metastases will be included in this study.

ClinicalTrials.gov Identifier: NCT02208804

 

Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study (HEPAR Plus)

Phase II

48 Patients with gastroenteropancreatic neuroendocrine tumours (NET) will be included in this study.

ClinicalTrials.gov Identifier: NCT02067988

 

Feasibility of holmium-166 microspheres for selective intratumoral treatment in head and neck cancer: biodistribution and safety in patients with malignancy of the tongue (HIT)

Phase I

20 Patients with T1-2 squamous cell carcinoma of the tongue, who are eligible for local surgery, will be included in this study.

ClinicalTrials.gov Identifier: NCT02975739

QuiremSpheres® and Q-Suite™ are not available for sale in all countries. This information is provided only in respect to markets where QuiremSpheres® and Q-Suite™ are approved or cleared. QuiremSpheres® and Q-Suite™ s not FDA cleared in the US for sale.

 

QuiremSpheres® microspheres are based on more than 15 years of research and development and we are continuously expanding our clinical evidence base. Clinical studies
QuiremSpheres® microspheres are based on more than 15 years of research and development and we are continuously expanding our clinical evidence base. Clinical studies
Clinical studies