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

Inclusion Criteria10

A. Preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy.
B. Planned Risk-reducing mastectomy, if it would be considered for upfront SLND due to institutional practice or in case of an individualised recommendation.
C. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to:
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
Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or
Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or
The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH).

Exclusion Criteria4

Intolerance/hypersensitivity to iron, dextran compounds or SPIO
An iron overload disease
Patient deprived of liberty or under guardianship
Pregnant or lactating patients

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.