500
Participants
Start Date
March 1, 2020
Primary Completion Date
December 30, 2026
Study Completion Date
December 30, 2027
Delayed SLND
"SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients have received SPIO in the breast at the first operation, prior to dissection and resection and the SLN has already been marked with SPIO. These SLNs are to be removed.~SLND is divided into the following steps:~1. Transcutaneous signal~2. Incision in the axilla (skin, subcutaneous fat and fascia) and In situ signal~3. SLN identification in situ~4. SLN excision and signal ex vivo~5. Background axillary counts. For step d the radioactive counts are registered for each SLN that has been excised. When the procedure is completed successfully with SPIO, then background axillary isotope counts are registered and, if present, SLND continues as described above with the isotope as primary tracer."
Late SLND
"SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients will be injected with radioisotope in the operated breast before SLND according to standard of care. Any SLNs detected with this intervention are to be removed.~SLND is divided into the following steps:~1. Transcutaneous signal~2. Incision in the axilla (skin, subcutaneous fat and fascia) and In situ signal~3. SLN identification in situ~4. SLN excision and signal ex vivo~5. Background axillary counts. For step d the magnetic counts are registered for each SLN that has been excised. When the procedure is completed successfully with the isotope, then background axillary iSPIO counts are registered and, if present, SLND continues as described above with the SPIO as primary tracer."
RECRUITING
Skåne University Hospital, Lund
RECRUITING
Växjö County Hospital, Vaxjo
RECRUITING
Sahlgrenska University Hospital, Gothenburg
RECRUITING
Linköping University Hospital, Linköping
RECRUITING
Västmanland County Hospital, Västerås
RECRUITING
Uppsala University Hospital, Uppsala
RECRUITING
Baylor College Of Medicine, Houston
RECRUITING
Falun Lasarett, Falun
RECRUITING
The University of Hong Kong-Shenzhen Hospital, Hong Kong
Västmanlands Hospital, Västerås, Sweden
UNKNOWN
Sahlgrenska University Hospital
OTHER
University Hospital, Linkoeping
OTHER
Skane University Hospital
OTHER
Blekinge County Council Hospital
OTHER
Växjö Hospital, Växjö, Sweden
UNKNOWN
The University of Hong Kong-Shenzhen Hospital
OTHER
Norrlands University Hospital
OTHER
Dalarna County Hospital, Falun, Sweden
UNKNOWN
Baylor College of Medicine
OTHER
Uppsala University
OTHER