Clinical trial NCT06104371: Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Keywords: sentinel lymph node detection
neoadjuvant chemotherapy
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala University
name: Region Västmanland
name: University Hospital, Linkoeping
name: Baylor College of Medicine
name: The University of Hong Kong-Shenzhen Hospital
name: Royal Marsden NHS Foundation Trust
name: University of Athens
name: University College Dublin
First posted: 2023-10-27
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients planned for preoperative chemotherapy before breast surgery.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sentinel lymph node detection rate
timeFrame: Perioperatively
Secondary outcomes:
measure: Number of sentinel lymph nodes detected per tracer
timeFrame: Perioperatively
measure: Concordance of nodes per tracer
timeFrame: Perioperatively
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References: