This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy.
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Average tumour dose by SPECT imaging
To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the average tumour absorbed dose in Gy calculated on SPECT.
Time frame: At 1 week after intervention
Microsphere distribution by MRI
Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose.
Time frame: At 1 week after intervention
Microsphere distribution by CT
Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.
Time frame: At 1 week after intervention
Number of treatment-related adverse events as assessed by CTCAE v4.0
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.
Time frame: Up to 3 months after intervention
Tumor response by RECIST 1.1
Tumor response to the intervention is evaluated according to the Response evaluation criteria in solid tumors (RECIST) version 1.1 after 3 months.
Time frame: At 3 months after intervention
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