Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. (MagLocal)

June 15, 2024 updated by: Professor Fredrik Warnberg, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Göteborg
      • Gothenburg, Göteborg, Sweden, 41345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tumour localisation with Magseed
Before preoperative chemotherapy a Magseed is inserted in the breast tumour
Device: Magseed
Tumour localizer
Active Comparator: 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.
Device: Metallic clip and guide wire
Tumour localizers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen volume
Time Frame: Perioperatively
The surgical specimen is weighed after removal.
Perioperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Roger Olofsson Bagge, prof, Sahlgrenska Academy at Gothenburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUGBG-2023001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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