Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.

NCT ID: NCT06463600

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Conserving Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One part feasibility and one part randomised.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tumour localisation with Magseed

Before preoperative chemotherapy a Magseed is inserted in the breast tumour

Group Type EXPERIMENTAL

Magseed

Intervention Type DEVICE

Tumour localizer

Metallic marker + guide wire

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

Group Type ACTIVE_COMPARATOR

Metallic clip and guide wire

Intervention Type DEVICE

Tumour localizers

Interventions

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Magseed

Tumour localizer

Intervention Type DEVICE

Metallic clip and guide wire

Tumour localizers

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor Fredrik Warnberg

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roger Olofsson Bagge, prof

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Academy at Gothenburg University

Locations

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Sahlgrenska Academy at Gothenburg University

Gothenburg, Göteborg, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Fredrik Warnberg, prof

Role: CONTACT

+46706146251

Kian Chin, MD

Role: CONTACT

+46702316011

Facility Contacts

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Fredrik Warnberg, prof

Role: primary

+46706146251

Kian Chin, MD

Role: backup

+46702316011

Other Identifiers

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SUGBG-2023001

Identifier Type: -

Identifier Source: org_study_id

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