Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients (MagSnow2)

January 25, 2024 updated by: Roger Olofsson Bagge, Vastra Gotaland Region

Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

This is a prospective cohort study where all research persons have SLN biopsy using both SPIO and the dual technique. Then the investigators will compare SLN detection rates between Magtrace 0.1 ml and the dual routine technique with radioactive tracer (Technetium99m, Tc99) +/- blue dye.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

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 Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Sahlgrenska Iniversity Hospital

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:

  • Planned for sentinel lymph node biopsy at (or after) breast surgery
  • Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Iron overload disease
  • Known hypersensitivity to iron, dextran compounds or blue dye.
  • Inability to understand given information and give informed consent or undergo study procedures

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sentinel node detection with 0.1mL SPIO and Technetium99
An intradermal injection of SPIO (MagTrace®), according to the pre-specified dose of 0.1mL, will be performed 7 days, up to the day of surgery. The injection should be in the skin over the tumour, or at the border of the areola. All patients will also receive technetium per routine.
Drug: Superparamagnetic Iron Oxide
Superparamagnetic iron oxide (SPIO) consists of an iron oxide nanoparticle core and a hydrophilic coating to make it biocompatible and colloidal stable in a suspension. In this study injected intradermally in an ultra-low dose
Other Names:
  • Magtrace
Device: Technetium99
Technetium99 +/- blue dye is injected per routine as a comparator and as back up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLN detection rate for Magtrace 0.1 ml and for dual technique (Tc99 +/- blue dye) measured as per cent of patients where a SLN is identified using either the magnetic or the dual technique.
Time Frame: During the procedure
percentage
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Magtrace artefacts
Time Frame: 3-6, 12 and 24-36 months postoperatively
Measured as per cent of patients with remaining artefacts evaluated by blinded central review.
3-6, 12 and 24-36 months postoperatively
Skin staining due to injected Magtrace
Time Frame: 4 weeks, 12, 24 and 36 months postoperatively
Measured as per cent of patients with remaining brown or blue skin staining and stain size, evaluated by the investigator and the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ)
4 weeks, 12, 24 and 36 months postoperatively
Rate of device-related AE and SAEs
Time Frame: During the procedure
Number
During the procedure
Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye)
Time Frame: During the procedure
Numbers
During the procedure
Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye)
Time Frame: During the procedure
percentage
During the procedure

Collaborators and Investigators

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

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Fredrik Wärnberg, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 18, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUGBG-2022002

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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