Clinical trial · Interventional
Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma
Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma: A Pilot Study
NCT03817307CI-TRIAL-00061696USPIO-NECKunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the diagnostic accuracy of USPIO enhanced MRI for the detection of lymph node metastases in head-and-neck squamous cell carcinoma (SCC) using histopathology as a gold standard.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
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
- The contrast agent ferumoxtran-10 will be administered intravenously under constant medical supervision 24-36 hours before performing a T2\* weighted MRI scan (prior to surgery).
- interventionNames
- Diagnostic Test: USPIO-enhanced MRI
Primary outcomes (1)
- measure
- Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a level basis.
- timeFrame
- The data of each patient will be assessed prior to neck dissection surgery.
- description
- The images of the USPIO-enhanced MRI will be read by two radiologists who will score each level as cancer (metastases) positive or negative. These results will be compared with the results of pathology which serve as the gold standard to determine the sensitivity, specificity, positive predictive value and negative predictive value of the USPIO-enhanced MRI for detecting lymph node metastases in head-and-neck cancer patients.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histopathologically proven cT0-4N0-3M0 SCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown primary. * Patients planned to undergo a neck dissection. * Patient provided written informed consent. Exclusion Criteria: * Patients who underwent radio- and/or chemotherapy to the neck before surgery. * Patients who had a previous lymphadenectomy in the head and neck region. * Patients with contraindications to MRI (epilepsy; claustrophobia; metallic splinters; pacemaker, pacemaker wires or implanted defibrillator; implanted magnets in jaw; arterial clips (carotid arteries); pregnancy; auditory implant, neurogenic bladder stimulator, insulin pump, neurostimulator, baclofen pump; metallic tissue expander after mastectomy; cochlear implant; metallic braces; other foreign bodies implanted) * Patients with contraindications to USPIO based contrast agents (prior allergic reaction to ferumoxtran-10 or any other iron preparation; prior allergic reaction attributed to dextran or other polysaccharide, in any preparation; hereditary hemochromatosis, hemosiderosis, chronic hemolytic anaemia (e.g. thalassemia, sickle cell anaemia); pregnancy) * Unable to provide informed consent.
References
Publications (1)
- DERIVEDDriessen DAJJ, Zamecnik P, Dijkema T, Pegge SAH, van Engen-van Grunsven ACH, Takes RP, Kaanders JHAM, Scheenen TWJ. High-Accuracy Nodal Staging of Head and Neck Cancer With USPIO-Enhanced MRI: A New Reading Algorithm Based on Node-to-Node Matched Histopathology. Invest Radiol. 2022 Dec 1;57(12):810-818. doi: 10.1097/RLI.0000000000000902. Epub 2022 Jul 1. PMID 35776432