Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using a low dose of Magtrace to locate lymph nodes in breast cancer patients

Official title: Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

Run by Vastra Gotaland Region · NCT06169072 · Data updated 2026-11-12

This study is testing if a low dose of a new tracer can help find lymph nodes in breast cancer patients as well as the traditional methods do.

More Breast Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment220 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedJuly 1, 2024
Study endsJuly 1, 2027
Registry record updatedJanuary 26, 2024
Trial IDNCT06169072 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are breast cancer patients scheduled for sentinel lymph node biopsy.

Probably not a fit

Patients who are pregnant, breastfeeding, or have iron overload disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose for sentinel lymph node (SLN) detection in breast cancer patients. Participants will undergo SLN biopsy using both the SPIO method and the traditional dual technique involving Technetium99m and possibly blue dye. The study will compare the detection rates of SLNs between these two methods and assess any MRI breast artefacts and skin staining over time. This prospective cohort study will provide insights into the non-inferiority of the new technique compared to the standard approach.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective method for sentinel lymph node detection in breast cancer patients.

How similar studies have gone: Other studies have shown promise with similar approaches using superparamagnetic nanoparticles, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Planned for sentinel lymph node biopsy at (or after) breast surgery
* Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria:

* Pregnant or breast-feeding
* Iron overload disease
* Known hypersensitivity to iron, dextran compounds or blue dye.
* Inability to understand given information and give informed consent or undergo study procedures

Where it's running

  • Sahlgrenska Iniversity Hospital
    Gothenburg, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.