Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Recruiting Phase 3 Interventional Study
DCIS Breast Cancer Breast Neoplasms Sentinel Lymph Node
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Uppsala University · Other
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About This Trial
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 BIR…
Trial Locations
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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…
Contacts

Andreas Karakatsanis, PhD

+46765864826

andreas.karakatsanis@surgsci.uu.se

CONTACT

Fredrik Wärnberg, PhD

fredrik.warnberg@vgregion.se

CONTACT