Breast Conserving SurgeryMagLocalNCT06463600
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
A study testing Magseed and Metallic clip and guide wire in people with Breast Conserving Surgery, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Conserving Surgery
- What is being tested?
- Magseed and Metallic clip and guide wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Planned for preoperative chemotherapy before breast cancer surgery
- Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
- SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
- Signed and dated written informed consent before the start of specific protocol procedures
Who cannot join
- Pregnant or breast-feeding
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
- Inability to understand given information and give informed consent or undergo study procedures
- Planned MRI control for tumour response during chemotherapy
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Academy at Gothenburg University
Gothenburg, Göteborg, 41345
Fredrik Warnberg, prof, +46706146251, fredrik.warnberg@vgregion.se
Kian Chin, MD, +46702316011, kian.chin@vgregion.se
About this study
Official title: Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.
Read the detailed description
The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.
- Conditions
- Breast Conserving Surgery
- Being tested
- Magseed, Metallic clip and guide wire
- Keywords
- Breast cancer, Tumour localisation, Magnetic clip, magnetic tracer, Preoperative 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.
MagseedDevice
Tumour localizer
Metallic clip and guide wireDevice
Tumour localizers
| Study group | Role | What they receive |
|---|---|---|
| Tumour localisation with Magseed | Experimental | Before preoperative chemotherapy a Magseed is inserted in the breast tumour Receives: Device: Magseed |
| Metallic marker + guide wire | Active comparator | Before preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip. Receives: Device: Metallic clip and guide wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specimen volume
The surgical specimen is weighed after removal.
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Conserving SurgeryStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One part feasibility and one part randomised.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Fredrik Warnberg, Sahlgrenska University Hospital
- Investigators
- Roger Olofsson Bagge, prof, Principal investigator, Sahlgrenska Academy at Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463600
- Sponsor's protocol ID
- SUGBG-2023001
- Acronym
- MagLocal
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
- ClinicalTrials.gov ID
- NCT06463600
- Acronym / sponsor ID
- MagLocal / SUGBG-2023001
- Conditions
- Breast Conserving Surgery
- Keywords
- Breast cancer, Tumour localisation, Magnetic clip, magnetic tracer, Preoperative chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jun 2024 (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.
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.
Detailed description
The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One part feasibility and one part randomised.
| Arm | Type | Receives |
|---|---|---|
| Tumour localisation with Magseed | Experimental | Device: MagseedBefore preoperative chemotherapy a Magseed is inserted in the breast tumour |
| Metallic marker + guide wire | Active comparator | Device: Metallic clip and guide wireBefore preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years
- Planned for preoperative chemotherapy before breast cancer surgery
- Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
- SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
- Signed and dated written informed consent before the start of specific protocol procedures
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
- Inability to understand given information and give informed consent or undergo study procedures
- Planned MRI control for tumour response during chemotherapy
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 |
|---|---|---|
| MagseedTumour localizer | Device | Tumour localisation with Magseed |
| Metallic clip and guide wireTumour localizers | Device | Metallic marker + guide wire |
Primary outcome
Specimen volume
Time frame: Perioperatively
The surgical specimen is weighed after removal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Roger Olofsson Bagge, prof principal investigator
Sahlgrenska Academy at Gothenburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magseed and Metallic clip and guide wire in people with Breast Conserving Surgery, run by Sahlgrenska University Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik 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?
Specimen volume (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 18 Jun 2024.