A randomised controlled trial comparing the standard dual technique to a novel magnetic technique for sentinel node biopsy in breast cancer
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Many women with breast cancer undergo sentinel lymph node biopsy in order to identify if the breast cancer has spread (metastasis) to the lymph nodes. This study is aimed at evaluating a new magnetic technique for identifying and localising the lymph nodes during sentinel lymph node biopsy.
- Registration Number
- EUCTR2015-000549-21-GB
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 99999
1) Male and female patients with breast cancer over the age of 18yrs
2) Patients who are clinically and radiologically node negative or patients who underwent a negative core biopsy or cytology of an ipsilateral axillary lymph node
3) Patients scheduled for SLNB
4) Patients who provided informed consent to participate in this study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 524
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1) Patients who are pregnant at the time of diagnosis
2) Known intolerance / hypersensitivity to methylene blue dye
3) Known intolerance / hypersensitivity to iron or dextran compounds
4) Patients who decline to receive radioisotope or blue dye for SLNB
5) Patients with a pacemaker or other implantable devices in the chest wall (Patients with implanted devices elsewhere in the body are allowed)
6) Patients undergoing SLNB prior to primary chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method