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Search / Trial NCT05625698

Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach

Launched by VASTRA GOTALAND REGION · Nov 22, 2022

Trial Information

Current as of August 11, 2025

Completed

Keywords

Neoadjuvant Chemotherapy, Sentinel Node, Axillary Clearance

ClinConnect Summary

Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy (tablet form), radiotherapy (radiation) and chemotherapy (intravenous / tablet form). During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.

Historically, all armpit lymph nodes (clearance) were removed irrespective of the stage of armpit disease which can lead to over-treatment and unnecessary long term arm lymphoedema (swelling). However, the modern approach has become more selective. If there are cancer s...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • * A patient meeting the following criteria is eligible for participation in the study:
  • Patients 18 years of age or older
  • Patients with breast cancer planned to undergo preoperative chemotherapy (NACT) with a) planned sentinel lymph node biopsy (SNB) or b) axillary lymph node dissection, in conjunction with the beast surgery after NACT
  • Exclusion Criteria:
  • Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
  • Patients who are required to undergo MR to evaluate tumour response
  • Pregnancy or breast feeding
  • Patients with an iron overload disease.
  • Patient deprived of liberty or under guardianship.
  • Inability to understand given information, give informed consent, undergo study procedures
  • MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI \> 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g. Pacemaker).

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

Fedrik Warnberg, MD PhD

Principal Investigator

Sahlgrenska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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