N/A
N=29
Magnetic Seed Localisation of Breast Cancers
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02635737 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Migration of Sentimark Device — 100 percentage of Magseed migrating >10mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sentimark (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Manchester University NHS Foundation Trust
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Migration of Sentimark Device |
100 | — |
| SECONDARY Accuracy of Initial Placement |
— | — |
| SECONDARY Percentage Magnetic Markers (Seeds) Within Target Area; |
100 | — |
| SECONDARY Depth of Marker (Seed) |
16 | — |
| SECONDARY Number of Seeds Detectable on the Sentimag Detector |
28 | — |
| SECONDARY Host Response to Implanted Seed Device |
50 | — |
Summary
This is a single site, single arm, unblinded safety and feasibility cohort study investigating the use of magnetic marker seeds to localise breast tumours.
Eligibility Criteria
Inclusion Criteria
- Participant is willing and able to give informed consent for participation in the study;
- Female, aged 18 years or above;
- Diagnosed with breast cancer (invasive or dcis);
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study;
- Undergoing mastectomy breast surgery.
Exclusion Criteria
- Patients with a Pacemaker or implanted device;
- Patients requiring an MRI scan prior to surgery;
- Patients with known coagulopathy or receiving anticoagulant medication including warfarin, heparin, clopidogrel or rivaroxaban;
- Patients receiving Neoadjuvant chemotherapy;
- Patients who are pregnant or lactating;
- Patients scheduled for immediate breast reconstruction;
- Patients who have received Sienna (iron oxide) injection in the previous six months;
- Patients with an existing breast haematoma close to the target lesion.
Data sourced from ClinicalTrials.gov (NCT02635737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.