Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

All patients receive intratumoral holmium microsphere injections ones, if surgery is suspended. Patient specific treamtent planning is performed for every individual patient.

Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy.

QuiremSpheres®

Frank Nijsen, PhD

This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.

Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer

Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Center, Non-randomized, Feasibility Study in an Open Surgical Setting - the SLOTH1 Study

To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the average tumour absorbed dose in Gy calculated on SPECT.

Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose.

Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.

Safety, expressed in Common Terminology Criteria for Adverse Events, grade 3 and higher, probably or definitely related to the implantation procedure or medical device implant is monitored up to 3 months after intervention.

Tumor response to the intervention is evaluated according to the Response evaluation criteria in solid tumors (RECIST) version 1.1 after 3 months.

Quirem Medical B.V.

Radboud University Medical Center

Symptoms and General Pathology

Neoplasm Metastasis

Liver Neoplasms

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

All patients receive holmium radioembolization as per usual

Radioembolization with QuiremSpheres® under MR imaging

This is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging.

Real-time Imaging of Holmium Radioembolization: a Feasibility Study

Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary or Secondary Liver Cancer; a Feasibility Study

Feasibility is defined as successful treatment under MRI in at least 4 of 6 patients. Unsuccessful treatment is defined as having to abort the procedure for safety reasons, judged by the interventional radiologist, and having to complete the administration of microspheres under X-ray guidance as in normal practice. Possible reasons for this are uncertainty about the location of the catheter, or luxation of the catheter as a result of transport to the MRI scanner.

Patients are followed up to 3 months after treatment, during which all adverse events are recorded.

MR based dosimetry is performed immediately after treatment, resulting in dose maps. The dose that the tumor received is divided over the dose that the rest of the liver received.

Voxel-based dosimetry will be performed, leading to dose-volume histograms with a dose value per voxel in Gray. Statistical testing will be done for differences between these data sets, i.e. the two different imaging modalities (MR based and SPECT based). It is expected that dose-volume histograms will be similar between the two modalities.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer	NCT05191498	Pancreas Cancer	QuiremSpheres®	18 Years -	Radboud University Medical Center
Real-time Imaging of Holmium Radioembolization: a Feasibility Study	NCT04269499	Liver Cancer Liver Metastase...	QuiremSpheres®	18 Years -	Radboud University Medical Center
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer	NCT05191498	Pancreas Cancer	QuiremSpheres®	18 Years -	Radboud University Medical Center

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