Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Launched by UPPSALA UNIVERSITY · Jan 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to perform sentinel lymph node biopsies in women diagnosed with ductal carcinoma in situ (DCIS), a type of early-stage breast cancer. The study is testing a special type of tracer called superparamagnetic iron oxide (SPIO) that is injected during the initial surgery. If the final results show invasive breast cancer, a follow-up surgery to check the lymph nodes (called delayed sentinel lymph node dissection) will be performed. This method aims to avoid unnecessary surgery for patients where immediate lymph node removal isn’t needed.

To participate in this trial, women aged 65 to 74 with a preoperative diagnosis of DCIS are eligible, especially if they are scheduled for a mastectomy or other specific procedures. Participants can expect to receive the SPIO injection during their first surgery and may undergo a second surgery later if needed. It's important to note that individuals with certain medical conditions, such as allergies to iron or those who are pregnant or breastfeeding, cannot join the study. This trial is currently recruiting participants who meet the criteria.

Gender

FEMALE

Eligibility criteria

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