NCT04311047

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started May 2017

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 24, 2021

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

February 26, 2020

Last Update Submit

September 19, 2021

Conditions

Pancreatic CancerPeriampullary Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Accuracy of USPIO MRI compared to CT

    From date of inclusion until date of resection, maximum 30 days.

Study Arms (1)

USPIO-enhanced MRI

EXPERIMENTAL

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

Interventions

USPIO-enhanced MRIDIAGNOSTIC_TEST

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

USPIO-enhanced MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, 6500, Netherlands

Location

Related Publications (1)

  • Litjens G, Nakamoto A, Brosens LAA, Maas MC, Scheenen TWJ, Zamecnik P, van Geenen EJM, Prokop M, van Laarhoven KJHM, Hermans JJ. Ferumoxtran-10-enhanced MRI for pre-operative metastatic lymph node detection in pancreatic, duodenal, or periampullary adenocarcinoma. Eur Radiol. 2024 Dec;34(12):7973-7984. doi: 10.1007/s00330-024-10838-w. Epub 2024 Jun 22.

    PMID: 38907886DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • John John, MD, PhD, Ir

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 17, 2020

Study Start

May 15, 2017

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

September 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)