Pancreatic Cancer Clinical Trial
— NANO-PANCOfficial title:
Preoperative Detection of Lymph Node Metastases in Pancreatic and Periampullary Carcinoma Using Ultrasmall Super Paramagnetic Iron Oxide Nanoparticle Ferumoxtran-10
Verified date | March 2021 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adenocarcinoma's of the pancreas and periampullary region (distal bile duct, ampulla of Vater and duodenum) are cancers with a poor survival. Good preoperative TNM staging is important to determine the appropriate therapy and prognosis. An important negative prognostic factor is the presence of para-aortic lymph node (LN) metastases which are regarded as distant metastases and precluding a curative resection. Determining LN status, however, is challenging. Ferrotran, (SPL Medical) an ultra-small superparamagnetic iron oxide (USPIO) particle, has proven to be a valuable contrast agent for detecting LN metastases of solid tumours, like prostate and breast cancer, using magnetic resonance imaging (MRI). The aim of this study is to validate USPIO-MRI to pathology in patients with pancreatic or periampullary cancer.
Status | Terminated |
Enrollment | 26 |
Est. completion date | March 1, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - High index of suspicion of locally resectable or borderline resectable pancreatic or periampullary (= duodenal, papilla of Vater or distal bile duct) cancer - Signed and dated informed consent Exclusion Criteria: - Pregnancy - Previous pancreatic surgery - Previous treatment for the pancreatic or periampullary cancer - Contraindications for 3T MRI - Contraindications for USPIO based contrast agents (allergy, hereditary hemochromatosis, thalassemia, sickle cell anemia) - Inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of USPIO MRI on a regional basis | Sensitivity and specificity of USPIO-enhanced MRI for the detection of lymph node metastases on a regional basis | From date of inclusion until date of resection, maximum 30 days. | |
Secondary | Accuracy of USPIO MRI compared to CT | Sensitivity and specificity of CT for detection of lymph node metastases. | From date of inclusion until date of resection, maximum 30 days. |
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