Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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 patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Planned for sentinel lymph node biopsy at (or after) breast surgery
• Signed and dated written informed consent before the start of specific protocol procedures
Locations
Other Locations
Sweden
Sahlgrenska Iniversity Hospital
RECRUITING
Gothenburg
Contact Information
Primary
Fredrik Wärnberg
fredrik.warnberg@vgregion.se
+4631823931
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 220
Treatments
Other: Sentinel node detection with 0.1mL SPIO and Technetium99
An intradermal injection of SPIO (MagTrace®), according to the pre-specified dose of 0.1mL, will be performed 7 days, up to the day of surgery. The injection should be in the skin over the tumour, or at the border of the areola. All patients will also receive technetium per routine.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region