Clinical trial · Interventional
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging for Sentinel Lymph Node Identification in Oral Cancer: a Feasibility Study
NCT04803331CI-TRIAL-00061721MAG-NODEunknownN/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)
To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
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 |
|---|---|---|---|
| SPIO-enhanced MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cT1-2N0M0 oral cancer patients
- description
- Patients undergo routine sentinel lymph node procedure (99mTc injection, planar imaging, SPECT-CT and surgery) for clinical purposes. After 99mTc injections and imaging has been executed peritumoral SPIO injections are performed by a medical doctor. A T2\*-weighted iron sensitive MRI scan is made 1 hour later.
- interventionNames
- Diagnostic Test: SPIO-enhanced MRI
Primary outcomes (1)
- measure
- MR (artefact) finetuning for optimization of SPIO dose and timing of MRI
- timeFrame
- 2 months
- description
- The first two patients will receive a dose of 0.012 ml SPIO. MR-images will be assessed. If this dose provides satisfactory MR-images (good visualization of lymph nodes without disturbing artefacts), subsequent patients will receive the same dose. If the artefact is too large, the dose will be decreased. If visualization is poor, the dose will be increased. The procedure will be repeated with adjusted doses each time in two patients until satisfactory MR-images are obtained. The investigators have established timing of MRI 1 hour after SPIO injection. It is assumed that after this time interval SPIO particles have had sufficient time to migrate to the SNs and to be taken up. However, if this interval appears to be too long because 'too many' SNs are visualized the time interval will be shortened. If this interval appears to be too short since no or too little SNs are visualized because SPIO uptake has not taken place yet, the time interval will be lengthened.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged \>18 years. * Patients with histopathologically proven cT1-2N0M0 squamous cell carcinoma of the oral cavity. * Patients planned to undergo routine sentinel node biopsy with 99mTc-radioisotope and SPECT-CT. * Patient provided written informed consent. Exclusion Criteria: * Patients who underwent previous surgery or radiotherapy to the neck. * Contra-indications to SPIO (Hypersensitivity to iron oxide or dextran compounds, Presence of iron overload disease (hereditary hemochromatosis, hemosiderosis, chronic hemolytic anemia (e.g. thalassemia, sickle cell anemia)) * Contra-indications to MRI: Epilepsy, Claustrophobia, Metallic splinters, Pacemaker, pacemaker wires or implanted defibrillator, Implanted magnets in jaw, Metallic 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 * Unable to provide informed consent.
References
Publications (1)
- DERIVEDHeldens GTN, Driessen DAJJ, Dijkema T, Arens AIJ, Zamecnik P, Pegge SAH, Weijs WLJ, van Engen-van Grunsven ACH, Takes RP, Kaanders JHAM, Scheenen TWJ. SPIO-enhanced MRI for sentinel lymph node mapping in oral cancer: a prospective feasibility study. Eur Radiol Exp. 2025 Nov 15;9(1):113. doi: 10.1186/s41747-025-00636-4. PMID 41241690