Breast CancerMAGPromNCT06610539
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
An observational study of Breast Cancer, run by Endomagnetics Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2025to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects considered for enrollment will be at least 18 years old at the time of consent, and: a) due to undergo planned breast conserving surgery (for example lumpectomy or partial mastectomy) and SLNB with Magtrace b) meet all other inclusion and no exclusion criteria
Who may be able to join
- Patient is willing and able to give informed consent for participation in the study
- Patient is aged 18 years or older at the time of consent
- Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace
Who cannot join
- The patient is pregnant or lactating
- The patient has had prior breast radiation to the ipsilateral breast
- The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
- The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
- The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
- The patient has iron overload disease
- The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNC, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Kristalyn Gallagher
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
About this study
Official title: A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.
Read the detailed description
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q.
Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of Breast Surgeons (ASBRS) performance standards.
All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed.
After completion of the surgery, at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator. Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit. Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration. They will then be asked to return at 6, 12, 18 and 24 months for follow-up visits, or until the discoloration has resolved. At each of these visits the BREAST-Q will be completed, and the size and severity assessment will be performed.
- Conditions
- Breast Cancer
- Keywords
- Magtrace, Sentinel Lymph Node Biopsy
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Measured: post-op to 24 month follow-up
Secondary outcomes (9)
Change in BREAST-Q score from post-operative visit through to resolution of skin discoloration or through 24 months, whichever is earlier, in the subgroup of patients with discoloration. 7 core scales will be used.
Measured: Baseline to 24 month follow-up
Change in BREAST-Q score from pre-operative visit to post-operative visit in patients with and without skin discoloration at the post-op follow-up visit.
Measured: Pre-op to Post-Op
Duration of discoloration over time post-op to resolution of discoloration or 24 month follow-up
Measured: Post-op to 24 month follow-up
Intensity of discoloration (absolute color and contrast to normal breast color) over time post-op to resolution of discoloration or 24 month follow-up
Measured: Post-Op to 24 month follow-up
Severity of discoloration over time post-op to resolution of discoloration or 24 month follow-up as assessed by height and width measurement
Measured: Post-Op to 24 month follow-up
Rates of device-related adverse events and serious device-related adverse events
Measured: Baseline to 24 month follow-up
Number of identified SLNs per patient
Number of identified SLNs per patient
Measured: Surgery
Number of non-Magtrace marked nodes per patient removed (clinically suspicious)
Number of non-Magtrace marked nodes per patient removed (clinically suspicious).
Measured: Surgery
Nodal malignancy rate
Nodal malignancy rate
Measured: Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start22 Apr 2025
- Primary completionJun 2028 (estimated)
- Study completionNov 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
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endomagnetics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endomagnetics Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610539
- Sponsor's protocol ID
- US-004
- Acronym
- MAGProm
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2024
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy
- ClinicalTrials.gov ID
- NCT06610539
- Acronym / sponsor ID
- MAGProm / US-004
- Conditions
- Breast Cancer
- Keywords
- Magtrace, Sentinel Lymph Node Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Endomagnetics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Endomagnetics Inc
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 24 Sep 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 purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.
Detailed description
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q.
Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of Breast Surgeons (ASBRS) performance standards.
All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed.
After completion of the surgery, at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator. Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit. Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration. They will then be asked to return at 6, 12, 18 and 24 months for follow-up visits, or until the discoloration has resolved. At each of these visits the BREAST-Q will be completed, and the size and severity assessment will be performed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects considered for enrollment will be at least 18 years old at the time of consent, and: a) due to undergo planned breast conserving surgery (for example lumpectomy or partial mastectomy) and SLNB with Magtrace b) meet all other inclusion and no exclusion criteria
Key inclusion criteria (3 listed)
- Patient is willing and able to give informed consent for participation in the study
- Patient is aged 18 years or older at the time of consent
- Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace
Key exclusion criteria (7 listed)
- The patient is pregnant or lactating
- The patient has had prior breast radiation to the ipsilateral breast
- The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
- The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
- The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Time frame: post-op to 24 month follow-up
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
9 secondary outcomes
Change in BREAST-Q score from post-operative visit through to resolution of skin discoloration or through 24 months, whichever is earlier, in the subgroup of patients with discoloration. 7 core scales will be used.
Time frame: Baseline to 24 month follow-up
Change in BREAST-Q score from pre-operative visit to post-operative visit in patients with and without skin discoloration at the post-op follow-up visit.
Time frame: Pre-op to Post-Op
Duration of discoloration over time post-op to resolution of discoloration or 24 month follow-up
Time frame: Post-op to 24 month follow-up
Intensity of discoloration (absolute color and contrast to normal breast color) over time post-op to resolution of discoloration or 24 month follow-up
Time frame: Post-Op to 24 month follow-up
Severity of discoloration over time post-op to resolution of discoloration or 24 month follow-up as assessed by height and width measurement
Time frame: Post-Op to 24 month follow-up
Rates of device-related adverse events and serious device-related adverse events
Time frame: Baseline to 24 month follow-up
Number of identified SLNs per patient
Time frame: Surgery
Number of non-Magtrace marked nodes per patient removed (clinically suspicious)
Time frame: Surgery
Nodal malignancy rate
Time frame: Surgery
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 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
RecruitingPhase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Endocrine Tumors, Non-Small Cell Lung Cancer
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
RecruitingPhase 2
Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC
Breast Cancer Recurrent
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.
2 sites 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 Endomagnetics Ltd. at 2 sites in United States.
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 7 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Vicky Crawford (+441223652617, vcrawford@endomag.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample (time frame: post-op to 24 month follow-up). 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 16 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.