Clinical trial · Interventional
Preoperative Detection of Lymph Node Metastases in Pancreatic and Periampullary Carcinoma Using USPIO MRI
Preoperative Detection of Lymph Node Metastases in Pancreatic and Periampullary Carcinoma Using Ultrasmall Super Paramagnetic Iron Oxide Nanoparticle Ferumoxtran-10
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We decided to stop inclusions and start analysis after 26 inclusions.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| USPIO-enhanced MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- USPIO-enhanced MRI
- description
- 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.
- interventionNames
- Diagnostic Test: USPIO-enhanced MRI
Primary outcomes (1)
- measure
- Accuracy of USPIO MRI on a regional basis
- timeFrame
- From date of inclusion until date of resection, maximum 30 days.
- description
- Sensitivity and specificity of USPIO-enhanced MRI for the detection of lymph node metastases on a regional basis
Secondary outcomes (1)
- measure
- Accuracy of USPIO MRI compared to CT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLitjens 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 38907886