oral cancer
Conditions
Interventions
A peritumoral injection with magnetic/ iron oxide nanoparticles (Sienna+) is
given, followed by an pre-operative MRI to localize the SLN. During elective
neck dissection (standard care), an addition
Sponsors
Universiteit Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients diagnosed with T1-T2 oral cancer scheduled for END and who have clinically and radiologically at maximum cN1,
Exclusion criteria
Exclusion criteria: - Positive result of ultrasound fine needle aspiration, for nodes >15mm and/or necrotic tissue; - Intolerance/ hypersensitivity to iron or dextran compounds or Sienna+; - Intolerance/ hypersensitivity to lidocaine; - Patients with an iron overload disease; - Patients with non-palpable malignancies; - Pregnant patients; - Patients with pacemakers or other implantable devices in the upper body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * The proportion of patients in which the SLNs could be detected (detection rate) using the magnetic method. * The proportion of sentinel nodes detected per patient during the SNB (in vivo) and after END, thus excised specimen (ex vivo). * The false-negative rate of detected SLNs based on the histopathological analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| * The proportion of sentinel nodes which could be localized per patient on the MRI; * Estimation of maximal distance needed to detect Sienna signal by SentiMag; * SNB duration/ total duration time. | — |
Countries
Netherlands
Outcome results
None listed