Sentinel Node Biopsy using Magnetic Nanoparticles for melanoma

Completed

• Conditions: Cancer; Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Melanoma

• Registration Number: ISRCTN15768185
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection rate with either the standard (blue dye and isotope) or the new technique (magnetic)<br>Timepoint(s): The proportion of sentinel nodes detected (detection rate) with either the standard or the new magnetic technique

Secondary Outcome Measures

Name	Time	Method
1. Evaluate surgeon's experience; Timepoint(s): Also to evaluate the surgeon's experience with the SentiMag technique and estimate the number of ope<br>2. Morbidity from SLNB; Timepoint(s): Morbidity from SLNB including lymphoedema, numbness, seroma, infection, cutaneous staining, chronic <br>3. MRI Scan; Timepoint(s): To evaluate the accuracy of MRI for the localisation of SLNs