Using nanoparticles for delayed lymph node biopsy in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients with ductal cancer in situ (DCIS) or unclear lesions. The approach allows for the identification of sentinel lymph nodes without upfront axillary surgery, which may be unnecessary in certain cases. Patients receive an injection of SPIO before their primary breast surgery, and if invasive cancer is confirmed post-surgery, only then is the axillary surgery performed. The study aims to improve surgical outcomes and reduce unnecessary procedures for patients diagnosed with DCIS.

Why it matters

Who can join: the full rules

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

Where it's running

• Baylor College Of Medicine
  Houston, Texas, United States Recruiting
• The University of Hong Kong-Shenzhen Hospital
  Hong Kong, Hong Kong Recruiting
• Falun Lasarett
  Falun, Dalarna County, Sweden Recruiting
• Växjö County Hospital
  Vaxjo, Kronoberg County, Sweden Recruiting
• Skåne University Hospital
  Lund, Skåne County, Sweden Recruiting
• Västmanland County Hospital
  Västerås, Västmanland County, Sweden Recruiting

Study contacts

• Principal investigator: Andreas Karakatsanis, PhD — Uppsala University
• Study coordinator: Andreas Karakatsanis, PhD
• Email: andreas.karakatsanis@surgsci.uu.se
• Phone: +46765864826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.