Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

NCT06104371 | Recruiting DMC

• 1 other identifier: SUGBG-2023002
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.

Conditions

Breast Cancer

Keywords

sentinel lymph node detection; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Sentinel lymph node detection rate

  per patient

  Perioperatively

Secondary Outcomes (2)

• Number of sentinel lymph nodes detected per tracer

  Perioperatively

• Concordance of nodes per tracer

  Perioperatively

Study Arms (2)

Node negative

Clinically node negative before neoadjuvant chemotherapy

Device: Magtrace

Node positive

Clinically node positive before neoadjuvant chemotherapy

Device: Magtrace

Interventions

Magtrace DEVICE

Sentinel lymph node tracer and metastatic lymph node clip

Also known as: Magseed

Node negative; Node positive

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients planned for preoperative chemotherapy before breast surgery.

You may qualify if:

• Patients 18 years of age or older.
• Patients with breast cancer planned to undergo NACT with
• planned sentinel lymph node dissection (SLND), or
• targeted axillary lymph node dissection (TAD), in conjunction with the
• breast surgery after NACT.

You may not qualify if:

• Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
• Patients who are required to undergo MRI to evaluate tumour response.
• Pregnancy or breast feedin.g
• Patients with an iron overload disease.
• Patient deprived of liberty or under guardianship.
• Inability to understand given information and give informed consent or undergo study procedure

Sponsors & Collaborators

• Region Västmanland: collaborator
• University Hospital, Linkoeping: collaborator
• Baylor College of Medicine: collaborator
• The University of Hong Kong-Shenzhen Hospital: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• University of Athens: collaborator
• University College Dublin: collaborator
• Vastra Gotaland Region: lead
• Uppsala University: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Fredrik AM Warnberg, prof

CONTACT

+46706146251; fredrik.warnberg@vgregion.se

Kian AM Chin, MD

CONTACT

+46702316011; kian.chin@vgregion.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 months

Locations

SE (1)