Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.

NCT06463600 | Recruiting

• 1 other identifier: SUGBG-2023001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Conserving Surgery

Keywords

Breast cancer; Tumour localisation; Magnetic clip; magnetic tracer; Preoperative chemotherapy

Outcome Measures

Primary Outcomes (1)

• Specimen volume

  The surgical specimen is weighed after removal.

  Perioperatively

Study Arms (2)

Tumour localisation with Magseed

EXPERIMENTAL

Before preoperative chemotherapy a Magseed is inserted in the breast tumour

Device: Magseed

Metallic marker + guide wire

ACTIVE COMPARATOR

Before preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip.

Device: Metallic clip and guide wire

Interventions

Magseed DEVICE

Tumour localizer

Tumour localisation with Magseed

Metallic clip and guide wire DEVICE

Tumour localizers

Metallic marker + guide wire

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast conserving surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Planned for preoperative chemotherapy before breast cancer surgery
• Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
• SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
• Signed and dated written informed consent before the start of specific protocol procedures

You may not qualify if:

• Pregnant or breast-feeding
• Iron overload disease
• Known hypersensitivity to iron or dextran compounds
• Inability to understand given information and give informed consent or undergo study procedures
• Planned MRI control for tumour response during chemotherapy

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska Academy at Gothenburg University

Gothenburg, Göteborg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Roger Olofsson Bagge, prof

  Sahlgrenska Academy at Gothenburg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Warnberg, prof

CONTACT

+46706146251; fredrik.warnberg@vgregion.se

Kian Chin, MD

CONTACT

+46702316011; kian.chin@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: One part feasibility and one part randomised.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 18, 2024
• Study Start: February 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)