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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
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Periampullary Cancer Diagnostic Test: USPIO-enhanced MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Geke Litjens, MD +31243668392 g.litjens@radboudumc.nl
Contact: John Hermans, MD, PhD, Ir John.Hermans@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands, 6500
Contact: Geke Litjens, MD    +31243668392    g.litjens@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: John John, MD, PhD, Ir Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04311047    
Other Study ID Numbers: NL52657.091.15
2015-000822-12 ( EudraCT Number )
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No