Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.

Breast Conserving Surgery Clinical Trial

— MagLocal  

Official title:

Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463600
• Other study ID #: SUGBG-2023001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Fredrik Warnberg, prof
• Phone: +46706146251
• Email: fredrik.warnberg[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.

Description:

The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age above 18 years

2. Planned for preoperative chemotherapy before breast cancer surgery

3. Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique

4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed

5. Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria:

1. Pregnant or breast-feeding

2. Iron overload disease

3. Known hypersensitivity to iron or dextran compounds

4. Inability to understand given information and give informed consent or undergo study procedures

5. Planned MRI control for tumour response during chemotherapy

Related Conditions & MeSH terms

• Breast Conserving Surgery

Intervention

Device:
• Magseed
Tumour localizer
• Metallic clip and guide wire
Tumour localizers

Locations

Country	Name	City	State
Sweden	Sahlgrenska Academy at Gothenburg University	Gothenburg	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specimen volume	The surgical specimen is weighed after removal.	Perioperatively