Using nanoparticles for delayed lymph node biopsy in breast cancer patients
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).
This study is testing if using special nanoparticles can help breast cancer patients avoid unnecessary surgery by identifying important lymph nodes only when needed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Uppsala University Academic / other |
| Locations | 9 sites (Houston, Texas and 8 other locations) |
| Trial ID | NCT04722692 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women with a preoperative diagnosis of DCIS or unclear lesions who are planned for mastectomy or breast-conserving surgery.
Not a fit: Patients with confirmed invasive breast cancer or those not eligible for mastectomy or breast-conserving surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could minimize unnecessary surgeries for patients with DCIS, leading to better patient outcomes and reduced healthcare costs.
How similar studies have performed: Other studies have explored similar approaches with varying degrees of success, but this specific use of SPIO nanoparticles for delayed dissection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 8 other locations
- 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)
- Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Östra Götaland, Sweden (Recruiting)
Study contacts
- Principal investigator: Andreas Karakatsanis, PhD — Uppsala University
- Study coordinator: Andreas Karakatsanis, PhD
- Email: andreas.karakatsanis@surgsci.uu.se
- Phone: +46765864826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.