Status:

TERMINATED

Preoperative Detection of Lymph Node Metastases in Pancreatic and Periampullary Carcinoma Using USPIO MRI

Lead Sponsor:

Radboud University Medical Center

Conditions:

Pancreatic Cancer

Periampullary Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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 th...

Detailed Description

Rationale: Pancreatic ductal adenocarcinoma (PDA) is a devastating disease with a dismal prognosis which has not improved substantially in the past 40 years. A good preoperative TNM staging is of imp...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 15 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2021

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT04311047

Start Date

May 15 2017

End Date

March 1 2021

Last Update

September 24 2021

Active Locations (1)

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Radboudumc

Nijmegen, Netherlands, 6500