sentinel node biopsy Sienna+ SentiMag MRI
Conditions
Interventions
The Medisch Spectrum Twente will participate in the MRI subprotocol. As part of the MRI subprotocol, patients will undergo an MRI scan prior to the scheduled operation. The scan will take roughly 60 m
Sponsors
King's College London, Guy's & St Thomas' NHS Foundation Trust
Eligibility
Inclusion criteria
Inclusion criteria: Patients with primary cutaneous melanoma scheduled for SLNB and who are clinically AJCC stage IB-IIC. - Patients available for follow-up for at least 12 months.
Exclusion criteria
Exclusion criteria: Intolerance / hypersensitivity to iron or dextran compounds. - Patients who cannot / do not receive radioisotope for SLNB. - Patients with an iron overload disease. - Patients with pacemakers or other implantable devices in the chestwall. - Intolerance / hypersensitivity to patent blue dye in the centres where this is used routinely. - Patients who had previous surgery to the likely draining lymph node fields. - Patients with surgical scars between the primary biopsy site and the draining lymph node field(s) that may alter the lymphatic drainage. - Patients with pre-existing lymphedema at the primary biopsy site, either primary or secundary. - Patients who subsequently shown to have more than stage III disease. Exclusion criteria MRI-subprotocol: - Presence of implantable devices (electronically, magnetically, mechanically activated. E.g: cardioverter defibrillators, cardiac pacemakers) - Metallic splinters in the eye. - Ferromagnetic haemostatic clips in the central nervous system. - Claustrophobia. MRI should be avoided in the presence of relative contraindications for MRI: cochlear implants, other pacemakers, insulin pumps and nerve stimulators, prosthetic heart valves, lead wires or similar wires in-situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint: The proportion of sentinel nodes detected (detection rate) with either the standard (patent blue dye and radioisotope; or radioisotope alone) or the new technique (magnetic tracer and hand-held magnetometer). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measurements: Morbidity from SLNB including lymphoedema, numbness, seroma, infection, cutaneous staining, chronic pain and early locoregional recurrence. Outcome measurements MRI subprotocol: evaluate the accuracy of MRI for the localisation of the SLN. | — |
Outcome results
None listed