Clinical trial · Interventional
MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer
Preoperative MRI and Magnetometer-guided Intraoperative Sentinel Lymph Node Detection With Superparamagnetic Iron Oxide Nanoparticles (SPIO) in Patients With Vulvar Cancer - a Feasibility Study (POSVUC Pilot)
- 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)
The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis.
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 |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magtrace | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sentinel lymph node identification
- timeFrame
- Within 30 days after SPIO injection.
- description
- The number of lymph nodes identified preoperatively with SPIO-enhanced MRI and intraoperatively with a magnetometer compared to Technetium-99m scintigraphy and blue dye.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed primary VSCC \<4 cm, candidates for surgery with SLNB Age above 18 Signed and dated written consent before the start of specific protocol procedures. ECOG performance status 0-2 Exclusion Criteria: Contraindications for MRI such as electronic implants or severe claustrophobia Hip replacement Iron overload disease 4. Known hypersensitivity to iron or dextran compounds Inability to understand given information and give informed consent or undergo study procedure
References
Publications (0)
Data not yet available