Lymph Node Identification Using Magtrace and Magseed Befo... | NCT06104371

Studies
Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

NCT06104371

Sponsor

Vastra Gotaland Region

Status

Recruiting

Last Update Posted

Feb 23, 2026Actual

Enrollment

459Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Magtrace

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Oct 23, 2023

First Submission Date that Met QC Criteria

Oct 23, 2023

First Posted Date

Oct 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2026

Last Update Posted Date

Feb 23, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roger Olofsson Bagge, professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Vastra Gotaland RegionOTHER_GOV

Collaborators

Name	Class
Uppsala University	OTHER
Region Västmanland	OTHER
University Hospital, Linkoeping	OTHER
Baylor College of Medicine

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.

Detailed Description

This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes.

Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.

All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

459Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Node negative		Clinically node negative before neoadjuvant chemotherapy	Device: Magtrace
Node positive		Clinically node positive before neoadjuvant chemotherapy	Device: Magtrace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magtrace	Device	Sentinel lymph node tracer and metastatic lymph node clip	Node negative Node positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sentinel lymph node detection rate	per patient	Perioperatively

Secondary Outcomes

Measure	Description	Time Frame
Number of sentinel lymph nodes detected per tracer	per node	Perioperatively
Concordance of nodes per tracer	Ratio	Perioperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients 18 years of age or older.
Patients with breast cancer planned to undergo NACT with
- planned sentinel lymph node dissection (SLND), or
- targeted axillary lymph node dissection (TAD), in conjunction with the
breast surgery after NACT.

Exclusion Criteria:

Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
Patients who are required to undergo MRI to evaluate tumour response.
Pregnancy or breast feedin.g
Patients with an iron overload disease.
Patient deprived of liberty or under guardianship.
Inability to understand given information and give informed consent or undergo study procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

All patients planned for preoperative chemotherapy before breast surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fredrik AM Warnberg, prof	Contact	+46706146251		fredrik.warnberg@vgregion.se
Kian AM Chin, MD	Contact	+46702316011		kian.chin@vgregion.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital	Recruiting	Gothenburg		413 45	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

ON request. Pseudoanonymised data.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

2 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided