Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Summary

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.

Conditions

• DCIS
• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Västmanlands Hospital, Västerås, Sweden

  collaborator UNKNOWN

• Sahlgrenska University Hospital

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Blekinge County Council Hospital

  collaborator OTHER

• Växjö Hospital, Växjö, Sweden

  collaborator UNKNOWN

• The University of Hong Kong-Shenzhen Hospital

  collaborator OTHER

• Norrlands University Hospital

  collaborator OTHER

• Dalarna County Hospital, Falun, Sweden

  collaborator UNKNOWN

• Baylor College of Medicine

  collaborator OTHER

• Uppsala University

  lead OTHER

Principal Investigators

• Andreas Karakatsanis, PhD · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2026-12-30

Completion

2027-12-30

FDA Drug

Yes

Countries

• United States
• Hong Kong
• Sweden

Study Locations