Topic: National Cancer Research Network
Conditions
Interventions
1. Ex-vivo MRI: In centres that participate in the ex-vivo MRI sub protocol an ex-vivo MRI scan from the sentinel lymph nodes is performed.
2. Injection magnetic tracer: The magnetic tracer is injecte
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with primary cutaneous melanoma scheduled for SLNB and who are clinically AJCC stage IB-IIC. 2. Patients available for follow-up for at least 12 months Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Intolerance / hypersensitivity to iron or dextran compounds 2. Patients who cannot / do not receive radioisotope for SLNB 3. Patients with pacemakers or other implantable devices in the chest wall 4. Patients who had previous surgery to the likely draining lymph node fields 5. Patients with surgical scars between the primary biopsy site the draining lymph node field that may alter the lymphatic drainage pattern 6. Patients with pre-existing lymphedema at the primary biopsy site, either primary or secondary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate with either the standard (blue dye and isotope) or the new technique (magnetic) Timepoint(s): The proportion of sentinel nodes detected (detection rate) with either the standard or the new magnetic technique | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate surgeon's experience; Timepoint(s): Also to evaluate the surgeon's experience with the SentiMag technique and estimate the number of ope 2. Morbidity from SLNB; Timepoint(s): Morbidity from SLNB including lymphoedema, numbness, seroma, infection, cutaneous staining, chronic 3. MRI Scan; Timepoint(s): To evaluate the accuracy of MRI for the localisation of SLNs | — |
Countries
United Kingdom
Outcome results
None listed