1) Sentinel Lymph Node metastases in melanoma patients 2) Cancer in the Sentinel Lymph Node(s)
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
Sponsors
King's College London
Eligibility
Age
18 Years to 99 Years
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 (as we will not have staged everyone preop to SNB, there can be some patients found to have stage IV disease postop SNB with large positive tumour load who are not detected by clinical examination alone-as imaging is not routine preoperative SNB).;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. | — |
Countries
Netherlands
Outcome results
None listed