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| Name | Class |
|---|---|
| Quirem Medical B.V. | INDUSTRY |
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This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study patients | Experimental | All patients receive intratumoral holmium microsphere injections ones, if surgery is suspended. Patient specific treamtent planning is performed for every individual patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuiremSpheres® | Device | Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 1 week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Microsphere distribution by MRI | Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose. | At 1 week after intervention |
| Microsphere distribution by CT |
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Inclusion Criteria:
Female or male aged 18 years and over.
Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines:
i. 1o-90o contact between tumor and the superior mesenteric artery, celiac axis or common hepatic artery. Or; ii. 90o-270o contact between tumor and superior mesenteric vein or portal vein, without occlusion.
iii. The discussion on resectability has to be made in consensus at multidisciplinary meetings/discussions and may overrule the above criteria (i, ii).
Patient is deemed eligible for surgical resection of the pancreatic cancer, however, during open surgery a more advanced disease than initially anticipated is found and resection is no longer feasible.
Life expectancy of 12 weeks or longer.
World Health Organisation (WHO) Performance status 0-1.
One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
Negative pregnancy test for women of childbearing potential.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Nijsen, PhD | Associate professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Centre | Nijmegen | Gelderland | 6525GA | Netherlands |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.
| 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. | 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. | At 3 months after intervention |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |