MelaMag Multicentre Trial
- Conditions
- sentinel node biopsySienna+SentiMagMRI
- Registration Number
- NL-OMON23789
- Lead Sponsor
- King's College London, Guy's & St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 176
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secundary outcome measurements: <br />Morbidity from SLNB including lymphoedema, numbness, seroma, infection, cutaneous staining, chronic pain and early locoregional recurrence. <br><br /><br /><br>Outcome measurements MRI subprotocol: evaluate the accuracy of MRI for the localisation of the SLN.