Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ (NCT04722692)
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).
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Baylor College Of Medicine — Houston, Texas
Age range: 18 Years
🧪 Interventions in This Study
- Delayed SLND (DIAGNOSTIC_TEST)
- Late SLND (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Baylor College Of Medicine — Houston, Texas
- The University of Hong Kong-Shenzhen Hospital — Hong Kong,
- Falun Lasarett — Falun, Dalarna County
- Växjö County Hospital — Vaxjo, Kronoberg County
- Skåne University Hospital — Lund, Skåne County
- Västmanland County Hospital — Västerås, Västmanland County
- Sahlgrenska University Hospital — Gothenburg, Västra Götaland County
- Uppsala University Hospital — Uppsala,
- Linköping University Hospital — Linköping, Östra Götaland
📞 Contact the Study Coordinator
Phone: +46765864826
Email: andreas.karakatsanis@surgsci.uu.se
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in DCIS
- Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS — Anchorage, Alaska
- Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS) — Calgary, Alberta
- The PREDICT Registry: — Scottsdale, Arizona
Explore by condition: All DCIS clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.