Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Breast Cancer Clinical Trial

— SentiNeo2  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104371
• Other study ID #: SUGBG-2023002
• Status: Not yet recruiting
• Start date: December 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Vastra Gotaland Region
• Contact: Fredrik AM Warnberg, prof
• Phone: +46706146251
• Email: fredrik.warnberg[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 459
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Magtrace
Sentinel lymph node tracer and metastatic lymph node clip

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (9)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Baylor College of Medicine, Region Västmanland, Royal Marsden NHS Foundation Trust, The University of Hong Kong-Shenzhen Hospital, University College Dublin, University Hospital, Linkoeping, University of Athens, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel lymph node detection rate	per patient	Perioperatively
Secondary	Number of sentinel lymph nodes detected per tracer	per node	Perioperatively
Secondary	Concordance of nodes per tracer	Ratio	Perioperatively