NCT06169072

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
14mo left

Started Jan 2023

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2023Jul 2027

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

November 18, 2023

Last Update Submit

January 25, 2024

Conditions

Breast CancerSentinel Lymph Node

Keywords

Breast cancerSentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

  • 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.

    percentage

    During the procedure

Secondary Outcomes (5)

  • MRI Magtrace artefacts

    3-6, 12 and 24-36 months postoperatively

  • Skin staining due to injected Magtrace

    4 weeks, 12, 24 and 36 months postoperatively

  • Rate of device-related AE and SAEs

    During the procedure

  • Numbers of nodes detected and removed for Magtrace 0.1 ml and for the dual technique (Tc99 +/- blue dye)

    During the procedure

  • Concordance between detected SLN by Magtrace 0.1 ml or by the dual technique (Tc +/- blue dye)

    During the procedure

Study Arms (1)

Sentinel node detection with 0.1mL SPIO and Technetium99

OTHER

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 OxideDevice: Technetium99

Interventions

Superparamagnetic Iron OxideDRUG

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

Also known as: Magtrace
Sentinel node detection with 0.1mL SPIO and Technetium99
Technetium99DEVICE

Technetium99 +/- blue dye is injected per routine as a comparator and as back up.

Sentinel node detection with 0.1mL SPIO and Technetium99

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned for sentinel lymph node biopsy at (or after) breast surgery
  • 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, dextran compounds or blue dye.
  • Inability to understand given information and give informed consent or undergo study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Iniversity Hospital

Gothenburg, 41345, Sweden

RECRUITING

Related Publications (6)

  • Balch CM. Detection of melanoma metastases with the sentinel node biopsy: the legacy of Donald L. Morton, MD (1934-2014). Clin Exp Metastasis. 2018 Aug;35(5-6):425-429. doi: 10.1007/s10585-018-9908-8. Epub 2018 May 31.

    PMID: 29855858BACKGROUND

  • Waanders S, Visscher M, Wildeboer RR, Oderkerk TO, Krooshoop HJ, Ten Haken B. A handheld SPIO-based sentinel lymph node mapping device using differential magnetometry. Phys Med Biol. 2016 Nov 21;61(22):8120-8134. doi: 10.1088/0031-9155/61/22/8120. Epub 2016 Oct 26.

    PMID: 27782005BACKGROUND

  • Karakatsanis A, Daskalakis K, Stalberg P, Olofsson H, Andersson Y, Eriksson S, Bergkvist L, Warnberg F. Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer. Br J Surg. 2017 Nov;104(12):1675-1685. doi: 10.1002/bjs.10606. Epub 2017 Sep 6.

    PMID: 28877348BACKGROUND

  • Mirzaei N, Katsarelias D, Zaar P, Jalnefjord O, Johansson I, Leonhardt H, Warnberg F, Olofsson Bagge R. Sentinel lymph node localization and staging with a low-dose of superparamagnetic iron oxide (SPIO) enhanced MRI and magnetometer in patients with cutaneous melanoma of the extremity - The MAGMEN feasibility study. Eur J Surg Oncol. 2022 Feb;48(2):326-332. doi: 10.1016/j.ejso.2021.12.467. Epub 2022 Jan 1.

    PMID: 35000820BACKGROUND

  • Karakatsanis A, Christiansen PM, Fischer L, Hedin C, Pistioli L, Sund M, Rasmussen NR, Jornsgard H, Tegnelius D, Eriksson S, Daskalakis K, Warnberg F, Markopoulos CJ, Bergkvist L. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc(99) and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies. Breast Cancer Res Treat. 2016 Jun;157(2):281-294. doi: 10.1007/s10549-016-3809-9. Epub 2016 Apr 27.

    PMID: 27117158BACKGROUND

  • Hersi AF, Pistiolis L, Dussan Luberth C, Vikhe-Patil E, Nilsson F, Mohammed I, Olofsson Bagge R, Warnberg F, Eriksson S, Karakatsanis A. Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial. Cancers (Basel). 2021 Feb 9;13(4):693. doi: 10.3390/cancers13040693.

    PMID: 33572114BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ferumoxides

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fredrik Wärnberg

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Wärnberg

CONTACT

+4631823931fredrik.warnberg@vgregion.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2023

First Posted

December 13, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2024

Study Completion (Estimated)

July 1, 2027

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)