RecruitingNCT06104371

Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0

Sponsor

Vastra Gotaland Region

Enrollment

459 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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.

Exclusion Criteria6

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