MagSNOLL: Magnetic Sentinel Node and Occult Lesion Localisation: A feasibility study using magnetic nano particles for sentinel node biopsy and localization of occult breast cancers.
Phase 2
Completed
- Conditions
- 1) Sentinel Lymph Node metastases and Occult lesion localisation in breast cancer patients. 2) Cancer in Sentinel Lymph nodes100062911000623210006295
- Registration Number
- NL-OMON44817
- Lead Sponsor
- niversiteit Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1) Patients (male or female) with histologically proven 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.
3) Patients with an iron overload disease
4) Patients with pacemakers or other implantable devices in the chest-wall.;Exclusion criteria MRI subprotocol:
1) Metallic splinters in the eye
2) Ferromagnetic haemostatic clips in the central nervous system.
3) Claustrophobia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method