NCT04722692 Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
| NCT ID | NCT04722692 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Uppsala University |
| Condition | DCIS |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2020-03-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Andreas Karakatsanis, PhD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT04722692 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying DCIS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04722692 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT04722692 currently recruiting?
Yes, NCT04722692 is actively recruiting participants. Contact the research team at andreas.karakatsanis@surgsci.uu.se for enrollment information.
Where is the NCT04722692 trial being conducted?
This trial is being conducted at Houston, United States, Hong Kong, Hong Kong, Falun, Sweden, Vaxjo, Sweden and 5 additional locations.
Who is sponsoring the NCT04722692 clinical trial?
NCT04722692 is sponsored by Uppsala University. The principal investigator is Andreas Karakatsanis, PhD at Uppsala University. The trial plans to enroll 500 participants.