Breast CarcinomaNCT05161507
Magseed and Magtrace Localization for Breast Cancer
An observational study of Breast Carcinoma and Breast Carcinoma Metastatic in Lymph Node, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Breast Carcinoma Metastatic in Lymph Node
- What is being tested?
- Magseed, Magtrace and Axillary lymph node metastasis - needle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteCzechia
- Study dates
- 4 May 2020to 31 Dec 2023
- Phase
- Observational
- 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
- All sexes
- Adult, Older adult
Study population: Patients with breast carcinoma
Who may be able to join
- Histologically confirmed cT0-4 breast cancer
- Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy
- With/ without received neoadjuvant chemotherapy prior to surgical resection
Who cannot join
- Distant metastases
- The subject is known to be pregnant
- Pacemaker of another implantable device in the chest wall
- Allergy to dextran or other iron-containing particles
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.
Read the detailed description
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. It also aims to follow skin discoloration after Magtrace injection and describe when and how it resolves. The Magtrace will be injected preoperatively. Sentinel node biopsy will be performed and detection rates will be recorded for both methods.
The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Intraoperative localization of the seed is achieved with the use of the Sentimag probe.
Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy. To accurately assess the response in the breast and the axilla, it is important that both the positive lymph node/s are marked before neoadjuvant systemic therapy to be able to locate them later on. Systemic therapy can negatively impact lymphatic drainage and hence reduce the accuracy of the sentinel lymph node biopsy (SLNB). However, when SLNB is paired with the removal of the previously positive target lymph node, a technique called Targeted Axillary Dissection, the operation becomes a lot more accurate, with lower morbidity of the patients.
A part of the study is also the verification of the time stability of breast tumor labeling with Magseed in the period from the onset of neoadjuvance to the subsequent operation following the oncological pretreatment of the patient.
All patients will undergo sentinel lymph node detection also by the classic detection system with Tc99.
Patients receive the Magseed marker via ultrasound-guided injection into a lymph node or to non-palpable breast cancer lesion.
After completion of the study, patients are followed up within 6-30 days post-surgery at our surgical clinic.
- Being tested
- Magseed, Magtrace, Axillary lymph node metastasis - needle biopsy
- Keywords
- Breast cancer, Sentinel lymph node, Super paramagnetic iron oxide, Magseed, Magtrace, Sentimag
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagseedProcedure or surgery
Patients with the non-palpable histologically confirmed breast cancer lesion - the tumor lesion will be labeled with Magseed and patient will undergo breast-conserving surgery and sentinel lymph node detection with Tc99.
MagtraceProcedure or surgery
Patients with the palpable histologically confirmed breast cancer lesion - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag. Patient will undergo sentinel lymph node detection with Tc99 and Sentimag localization system with breast surgery.
Axillary lymph node metastasis - needle biopsyProcedure or surgery
Patients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy, and later during target axillary dissection will be performed the biopsy of labeled lymph node during breast surgery.
| Study group | Role | What they receive |
|---|---|---|
| Non-palpable breast cancer lesion | Patients with the non-palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - the tumor lesion will be labeled with Magseed. Receives: Procedure: Magseed | |
| Palpable breast cancer lesion | Patients with the palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag. Receives: Procedure: Magtrace | |
| Axillary lymph node metastasis | Patients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy. Receives: Procedure: Axillary lymph node metastasis - needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Magseed placement
Accuracy of Magseed placement will be measured regarding its position towards the lymph node in mm. Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Other statistical methods, when appropriate, may be used for analysis.
Measured: During the surgical procedure
Surgeon-rated ease of detected lymph node localization and removal
Descriptive statistics will be used to summarize surgeon rated ease of localization.
Measured: During the surgical procedure
Number of nodes retrieved within the surgical specimen containing the Magseed
Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.
Measured: During the surgical procedure
Surgeon-rated ease of detected labeled lesion localization and removal
Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.
Measured: During the surgical procedure
Transcutaneous detection rate
Descriptive statistics will be used to summarize transcutaneous detection rate.
Measured: During the surgical procedure
Incidence of adverse events
Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
Measured: Up to 6 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start4 May 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Toman, MD, Principal investigator, University Hospital OstravaOtakar Kubala, MD,PhD, Study chair, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161507
- Sponsor's protocol ID
- CHIR-07-Sentimag
- Other IDs
- 05/RVO-FNOs/2020
- Status last verified
- Jan 2024
- First submitted
- 23 Sep 2020
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be made available to other researchers upon request.
Publications
Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15.
PubMed 25466980Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5.
PubMed 31166765Zacharioudakis K, Down S, Bholah Z, Lee S, Khan T, Maxwell AJ, Howe M, Harvey J. Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study. Eur J Surg Oncol. 2019 Nov;45(11):2016-2021. doi: 10.1016/j.ejso.2019.06.035. Epub 2019 Jun 26.
PubMed 31288944
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System
- ClinicalTrials.gov ID
- NCT05161507
- Acronym / sponsor ID
- CHIR-07-Sentimag
- Keywords
- Breast cancer, Sentinel lymph node, Super paramagnetic iron oxide, Magseed, Magtrace, Sentimag
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Dec 2021 (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 aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.
Detailed description
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. It also aims to follow skin discoloration after Magtrace injection and describe when and how it resolves. The Magtrace will be injected preoperatively. Sentinel node biopsy will be performed and detection rates will be recorded for both methods.
The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Intraoperative localization of the seed is achieved with the use of the Sentimag probe.
Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy. To accurately assess the response in the breast and the axilla, it is important that both the positive lymph node/s are marked before neoadjuvant systemic therapy to be able to locate them later on. Systemic therapy can negatively impact lymphatic drainage and hence reduce the accuracy of the sentinel lymph node biopsy (SLNB). However, when SLNB is paired with the removal of the previously positive target lymph node, a technique called Targeted Axillary Dissection, the operation becomes a lot more accurate, with lower morbidity of the patients.
A part of the study is also the verification of the time stability of breast tumor labeling with Magseed in the period from the onset of neoadjuvance to the subsequent operation following the oncological pretreatment of the patient.
All patients will undergo sentinel lymph node detection also by the classic detection system with Tc99.
Patients receive the Magseed marker via ultrasound-guided injection into a lymph node or to non-palpable breast cancer lesion.
After completion of the study, patients are followed up within 6-30 days post-surgery at our surgical clinic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-palpable breast cancer lesion | – | Procedure: MagseedPatients with the non-palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - the tumor lesion will be labeled with Magseed. |
| Palpable breast cancer lesion | – | Procedure: MagtracePatients with the palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag. |
| Axillary lymph node metastasis | – | Procedure: Axillary lymph node metastasis - needle biopsyPatients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with breast carcinoma
Key inclusion criteria (3 listed)
- Histologically confirmed cT0-4 breast cancer
- Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy
- With/ without received neoadjuvant chemotherapy prior to surgical resection
Key exclusion criteria (4 listed)
- Distant metastases
- The subject is known to be pregnant
- Pacemaker of another implantable device in the chest wall
- Allergy to dextran or other iron-containing particles
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 |
|---|---|---|
| MagseedPatients with the non-palpable histologically confirmed breast cancer lesion - the tumor lesion will be labeled with Magseed and patient will undergo breast-conserving surgery and sentinel lymph node detection with Tc99. | Procedure or surgery | Non-palpable breast cancer lesion |
| MagtracePatients with the palpable histologically confirmed breast cancer lesion - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag. Patient will undergo sentinel lymph node detection with Tc99 and Sentimag localization system with breast surgery. | Procedure or surgery | Palpable breast cancer lesion |
| Axillary lymph node metastasis - needle biopsyPatients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy, and later during target axillary dissection will be performed the biopsy of labeled lymph node during breast surgery. | Procedure or surgery | Axillary lymph node metastasis |
Primary outcome
Accuracy of Magseed placement
Time frame: During the surgical procedure
Accuracy of Magseed placement will be measured regarding its position towards the lymph node in mm. Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Other statistical methods, when appropriate, may be used for analysis.
Surgeon-rated ease of detected lymph node localization and removal
Time frame: During the surgical procedure
Descriptive statistics will be used to summarize surgeon rated ease of localization.
Number of nodes retrieved within the surgical specimen containing the Magseed
Time frame: During the surgical procedure
Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.
Surgeon-rated ease of detected labeled lesion localization and removal
Time frame: During the surgical procedure
Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.
Transcutaneous detection rate
Time frame: During the surgical procedure
Descriptive statistics will be used to summarize transcutaneous detection rate.
Incidence of adverse events
Time frame: Up to 6 weeks post-procedure
Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 25466980Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15.
- Background: PubMed 31166765Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5.
- Background: PubMed 31288944Zacharioudakis K, Down S, Bholah Z, Lee S, Khan T, Maxwell AJ, Howe M, Harvey J. Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study. Eur J Surg Oncol. 2019 Nov;45(11):2016-2021. doi: 10.1016/j.ejso.2019.06.035. Epub 2019 Jun 26.
- Individual participant dataSharing planned: No. Individual participant data will be made available to other researchers upon request.
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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.
Daniel Toman, MD principal investigator
University Hospital Ostrava
Otakar Kubala, MD,PhD study chair
University Hospital Ostrava
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 Carcinoma and Breast Carcinoma Metastatic in Lymph Node, run by University Hospital Ostrava at 1 site in Czechia.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jan 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Magseed placement (time frame: During the surgical procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161507, which also lists 3 linked publications.
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 26 Jan 2024.