RecruitingPhase 3NCT04722692

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Lesions of the Breast and How to Not do it. An Open-label, Phase 3, Randomised Controlled Trial. (SentiNot 2.0).

Sponsor

Uppsala University

Enrollment

500 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms Sentinel Lymph Node DCIS

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether it is safe and effective to delay or avoid sentinel lymph node biopsy (a procedure to check if cancer has spread to nearby lymph nodes) in patients diagnosed with ductal carcinoma in situ (DCIS) — a very early, non-invasive form of breast cancer — before surgery. The aim is to spare patients an unnecessary procedure when it may not be needed. **You may be eligible if:** - You have been diagnosed with DCIS (pre-invasive breast cancer) before surgery - You are planned for a mastectomy, complex surgery, or breast-conserving surgery with features that might ordinarily prompt a lymph node biopsy - Your doctor is uncertain whether a sentinel node biopsy is needed upfront **You may NOT be eligible if:** - You have an allergy or intolerance to iron or dextran compounds (used in the procedure) - You have an iron overload disease - You are pregnant or breastfeeding - You are under guardianship or have restricted legal rights Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTDelayed 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_TESTLate 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.