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Avoidance of unnecessary sentinel lymph node biopsies (SLNB) in patients with ductal carcinoma in situ (DCIS) undergoing mastectomy through the use of superparamagnetic iron oxide (SPIO, Magtrace®): a prospective cohort study

Avoidance of unnecessary sentinel lymph node biopsies (SLNB) in patients with ductal carcinoma in situ (DCIS) undergoing mastectomy through the use of superparamagnetic iron oxide (SPIO, Magtrace®): a prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040558
Enrollment
100
Registered
2026-06-16
Start date
2026-06-11
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D05.1

Interventions

Group 1: After obtaining written informed consent, 1 mL of Magtrace® will be injected into the affected breast up to 7 days before the planned mastectomy. During surgery, only the mastectomy will be

Sponsors

Rotkreuzklinikum München gGmbH
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: DCIS with indication for mastectomy

Exclusion criteria

Exclusion criteria: patients unable to provide informed consent

Design outcomes

Primary

MeasureTime frame
Number of delayed (secondary) sentinel lymph node biopsies performed and number of sentinel lymph node biopsies avoided.—

Secondary

MeasureTime frame
Pre- and postoperative quality of life assessed using standardized EORTC questionnaires Technical success rate of delayed sentinel lymph node biopsy Time interval to delayed sentinel lymph node biopsy Incidence of skin discoloration—

Countries

Germany

Contacts

Public ContactMoritz Hamann

Rotkreuzklinikum München gGmbH

moritz.hamann@swmbrk.de+4989130330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026