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

NCT04311047 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-09-24

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

USPIO-enhanced MRI

Administration of USPIO contrast 24-36 hours before MRI scan of the abdomen to detect lymph node metastases.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • John John, MD, PhD, Ir · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2020-12-01
Completion
2021-03-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311047 on ClinicalTrials.gov