Status:
RECRUITING
Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in...
Detailed Description
The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in...
Eligibility Criteria
Inclusion
- Planned for sentinel lymph node biopsy at (or after) breast surgery
- Signed and dated written informed consent before the start of specific protocol procedures
Exclusion
- Pregnant or breast-feeding
- Iron overload disease
- Known hypersensitivity to iron, dextran compounds or blue dye.
- Inability to understand given information and give informed consent or undergo study procedures
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06169072
Start Date
January 1 2023
End Date
July 1 2027
Last Update
January 26 2024
Active Locations (1)
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1
Sahlgrenska Iniversity Hospital
Gothenburg, Sweden, 41345