Preoperative Detection of Lymph Node Metastases in Pancreatic and Periampullary Carcinoma Using USPIO MRI (NANO-PANC)
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|ClinicalTrials.gov Identifier: NCT04311047|
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Periampullary Cancer||Diagnostic Test: USPIO-enhanced MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Detection of Lymph Node Metastases in Pancreatic and Periampullary Carcinoma Using Ultrasmall Super Paramagnetic Iron Oxide Nanoparticle Ferumoxtran-10|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: USPIO-enhanced MRI
Ferumoxtran-10 contrast will be intravenously administered 24-36 before performing an MRI scan. The MRI scan will be discussed with the surgeon prior to resection. Findings on MRI will be compared to pathology.
Diagnostic Test: USPIO-enhanced MRI
Administration of USPIO contrast 24-36 hours before MRI scan of the abdomen to detect lymph node metastases.
- Accuracy of USPIO MRI on a regional basis [ Time Frame: From date of inclusion until date of resection, maximum 30 days. ]Sensitivity and specificity of USPIO-enhanced MRI for the detection of lymph node metastases on a regional basis
- Accuracy of USPIO MRI compared to CT [ Time Frame: From date of inclusion until date of resection, maximum 30 days. ]Sensitivity and specificity of CT for detection of lymph node metastases.
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): NCT04311047
|Contact: Geke Litjens, MDfirstname.lastname@example.org|
|Contact: John Hermans, MD, PhD, Ir||John.Hermans@radboudumc.nl|
|Nijmegen, Netherlands, 6500|
|Contact: Geke Litjens, MD +31243668392 email@example.com|
|Principal Investigator:||John John, MD, PhD, Ir||Radboud University|