Real-time Imaging of Holmium Radioembolization: a Feasibility Study (Emeritus)
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|ClinicalTrials.gov Identifier: NCT04269499|
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Liver Metastases||Device: QuiremSpheres®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, interventional, feasibility|
|Masking:||None (Open Label)|
|Official Title:||Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary or Secondary Liver Cancer; a Feasibility Study|
|Actual Study Start Date :||November 11, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
All patients receive holmium radioembolization as per usual
Radioembolization with QuiremSpheres® under MR imaging
- Feasibility of MR imaged administration of holmium microspheres [ Time Frame: 1 month after inclusion ]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.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 3 months after treatment ]Patients are followed up to 3 months after treatment, during which all adverse events are recorded.
- Tumor/non-tumor ratio on MR based dosimetry [ Time Frame: 1 month after inclusion ]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.
- Comparison of dosimetry in Gray between MR based and SPECT based dose maps [ Time Frame: 1 month after inclusion ]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.
- Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria) [ Time Frame: 3 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269499
|Contact: Frank Nijsen, PhDemail@example.com|
|Contact: Joey Roosen, MDfirstname.lastname@example.org|
|Radboud University Medical Centre||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6525GA|
|Contact: Frank Nijsen, PhD +31640675781 email@example.com|
|Principal Investigator:||Frank Nijsen, PhD||Associate professor|