Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy (SentiNeo2)

Vastra Gotaland Region

Status

Begins enrollment in 2 months

Conditions

Breast Cancer

Treatments

Device: Magtrace

Study type

Observational

Funder types

Other

Identifiers

NCT06104371

SUGBG-2023002

Details and patient eligibility

About

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.

Full description

This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes.

Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.

All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.

Enrollment

459 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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