Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide (MAGSNOW)

March 24, 2025 updated by: Roger Olofsson Bagge, Vastra Gotaland Region

Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging and Magnetic Probe in Patients with Breast Cancer

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

This is a phase Ib/II interventional dose-escalation single arm study. There will be a dose escalation of SPIO (0.1ml, 0.25ml and 0.5 ml) with a minimum of 5 patients per step. If 4 or more procedures are successful, no further dose escalation will be performed. 30 patients will be included with the minimal successful dose.

Furthermore, a total of 20 patients with the minimal successful dose will be included for the secondary objective A - to evaluate if it is possible to map and stage sentinel lymph nodes with SPIO-enhanced axillary MRI. For the secondary objective B - an additional of 20 patients with the minimal successful dose will be included to evaluate if SPIO in a low dose creates any SPIO related artifacts on breast MRI after breast conserving surgery. These two parts of the study are optional, and the patients will be asked specifically about participation in these two objectives, A and B. All included patients will be evaluated for skin staining at study visits.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Sahlgrenska University 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female aged above 18 years
  2. Signed and dated written informed consent before the start of specific protocol procedures
  3. Histologically confirmed breast cancer planned for breast conserving surgery and sentinel lymph node biopsy

Exclusion Criteria:

  1. Pregnant or breast-feeding
  2. Iron overload disease
  3. Known hypersensitivity to iron, dextran compounds or blue dye.
  4. Inability to understand given information and give informed consent or undergo study procedures
  5. MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g., pacemaker) and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or imaging.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel node detection with 0.1mL SPIO
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
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.
Other Names:
  • MagTrace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sentinel lymph node detection rate compared to Tc99m and blue dye
Time Frame: During the procedure
To evaluate the use of superparamagnetic iron oxide (SPIO) as a tracer in a minimal lower dose (0.1-0.5 ml) for sentinel lymph node detection in breast cancer.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI artefacts in breast
Time Frame: 6 and 12 months after surgery
To evaluate if SPIO in a low dose creates any SPIO related breast MRI artefacts (assessed by breast MRI), reported as percentage of patients with artefacts present.
6 and 12 months after surgery
SPIO related skin staining
Time Frame: 6 and 12 months after surgery
To evaluate if SPIO in a low dose creates any SPIO related skin staining (assessed by photo), reported as percentage of patients with artefacts present.
6 and 12 months after surgery

Collaborators and Investigators

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

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Roger Olofsson Bagge, MD, PhD, Sahlgrenska University Hospital

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)

November 1, 2021

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUGBG-2021001

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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