Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUppsala University

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

500 Participants
are divided into 2 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