About this trial
The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.
Eligibility criteria
Qualifiers
Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or
Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or
Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or
Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or
Disqualifiers
Intolerance/hypersensitivity to iron, dextran compounds or SPIO
An iron overload disease
Patient deprived of liberty or under guardianship
Pregnant or lactating patients
Trial design
Treatments tested in this trial
- Delayed SLND
- Late SLND
Treatment groups
Sponsors and collaborators
Uppsala University
Lead sponsor
Västmanlands Hospital, Västerås, Sweden
Collaborator
Sahlgrenska University Hospital
Collaborator
University Hospital, Linkoeping
Collaborator
Skane University Hospital
Collaborator
Blekinge County Council Hospital
Collaborator
Växjö Hospital, Växjö, Sweden
Collaborator
The University of Hong Kong-Shenzhen Hospital
Collaborator
Norrlands University Hospital
Collaborator
Dalarna County Hospital, Falun, Sweden
Collaborator
Baylor College of Medicine
Collaborator