MagSNOLL multicenter Study
- Conditions
- Patients (male or female) with histologically proven non-palpable breast cancer visible on ultrasound and suitable for SLNB
- Registration Number
- NL-OMON26455
- Lead Sponsor
- Guy's and St Thomas Hospitals, UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1) Patients (male or female) with histologically proven non-palpable breast cancer visible on ultrasound and suitable for SLNB.
2) Patients available for follow-up for at least 12 months
Exclusion Criteria
1) Intolerance / hypersensitivity to iron or dextran compounds or Sienna+.
2) Patients who cannot/ do not receive radioisotope for SLNB.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: 1) Successful localisation (Confirmation that peak” SentiMag TM readings correspond to centre of the excised lesion on specimen radiograph).
- Secondary Outcome Measures
Name Time Method Secondary endpoints: 1) Margin involvement 2) re-operation rates 3) SLNB success rates (magnetic technique +/- blue dye and standard technique) 4) Volume of specimen 5) Weight of specimen 6) Operative time 7) Complications 8) Radiological localisation time 9) Patient recorded outcome measures. 10) Cost 11) Accuracy of MRI for the localization of SLNs.