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Search / Trial NCT06169072

Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

Launched by VASTRA GOTALAND REGION · Dec 10, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Cancer Sentinel Lymph Node Biopsy

ClinConnect Summary

This clinical trial is exploring a new method for locating sentinel lymph nodes in patients with breast cancer. The researchers want to see if using a very small amount (0.1 ml) of a special tracer called Magtrace, made from tiny iron particles, works just as well as the traditional method that uses a radioactive substance and sometimes a blue dye. Sentinel lymph nodes are the first lymph nodes that cancer cells are likely to spread to, so finding them accurately is important for treatment planning.

To participate, individuals should be planning to have a sentinel lymph node biopsy as part of their breast surgery and must be able to provide written consent. However, those who are pregnant, breastfeeding, have certain medical conditions related to iron, or have a known allergy to the substances used in the study won’t be eligible. Participants will receive the tracer during their procedure and will be monitored for any side effects, such as skin staining or issues with MRI scans, over time. This trial is currently recruiting participants of all genders aged 65 and older.

Gender

ALL

Eligibility 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

About Vastra Gotaland Region

Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.

Locations

Gothenburg, , Sweden

Patients applied

0 patients applied

Trial Officials

Fredrik Wärnberg

Principal Investigator

Sahlgrenska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported