Breast CancerSentiNeo2NCT06104371
Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy
An observational study of Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magtrace
- Type of treatment
- Medical device
- How many people
- 459 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients planned for preoperative chemotherapy before breast surgery.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
Roger Olofsson Bagge, Dr, +46 31 3428207, roger.olofsson.bagge@gu.se
Roger Olofsson Bagge, Dr
About this study
Official title: Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Magtrace
- Keywords
- sentinel lymph node detection, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagtraceDevice
Also called Magseed
Sentinel lymph node tracer and metastatic lymph node clip
| Study group | Role | What they receive |
|---|---|---|
| Node negative | Clinically node negative before neoadjuvant chemotherapy Receives: Device: Magtrace | |
| Node positive | Clinically node positive before neoadjuvant chemotherapy Receives: Device: Magtrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node detection rate
per patient
Measured: Perioperatively
Secondary outcomes (2)
Number of sentinel lymph nodes detected per tracer
per node
Measured: Perioperatively
Concordance of nodes per tracer
Ratio
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 459 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Uppsala University, Region Västmanland, University Hospital, Linkoeping, Baylor College of Medicine, The University of Hong Kong-Shenzhen Hospital, Royal Marsden NHS Foundation Trust, University of Athens, University College Dublin
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104371
- Sponsor's protocol ID
- SUGBG-2023002
- Acronym
- SentiNeo2
- Status last verified
- Feb 2026
- First submitted
- 23 Oct 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ON request. Pseudoanonymised data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0
- ClinicalTrials.gov ID
- NCT06104371
- Acronym / sponsor ID
- SentiNeo2 / SUGBG-2023002
- Conditions
- Breast Cancer
- Keywords
- sentinel lymph node detection, neoadjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 459 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Uppsala University, Region Västmanland, University Hospital, Linkoeping, Baylor College of Medicine, The University of Hong Kong-Shenzhen Hospital, Royal Marsden NHS Foundation Trust, University of Athens, University College Dublin
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Node negative | – | Device: MagtraceClinically node negative before neoadjuvant chemotherapy |
| Node positive | – | Device: MagtraceClinically node positive before neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients planned for preoperative chemotherapy before breast surgery.
Key inclusion criteria (5 listed)
- Patients 18 years of age or older.
- Patients with breast cancer planned to undergo NACT with
- breast surgery after NACT.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagtraceAlso: MagseedSentinel lymph node tracer and metastatic lymph node clip | Device | Node negative, Node positive |
Primary outcome
Sentinel lymph node detection rate
Time frame: Perioperatively
per patient
2 secondary outcomes
Number of sentinel lymph nodes detected per tracer
Time frame: Perioperatively
Concordance of nodes per tracer
Time frame: Perioperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Yes. ON request. Pseudoanonymised data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fredrik AM Warnberg, prof (+46706146251, fredrik.warnberg@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel lymph node detection rate (time frame: Perioperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.