MELAMAG Trial: SentiMAG Melanoma - Sentinel Node Biopsy using Magnetic Nanoparticles: A prospective multicentre feasibility non-randomised clinical trial to compare sentinel node biopsy using magnetic nanoparticles vs. standard technique.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint: The proportion of sentinel nodes detected (detection<br /><br>rate) with either the standard (patent blue dye and radioisotope; or<br /><br>radioisotope alone) or the new technique (magnetic tracer and hand-held<br /><br>magnetometer).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome measurements: Morbidity from SLNB including lymphoedema,<br /><br>numbness, seroma, infection, cutaneous staining, chronic pain and early<br /><br>locoregional recurrence.<br /><br><br /><br>Outcome measurements MRI subprotocol: evaluate the accuracy of MRI for the<br /><br>localisation of the SLN.</p><br>