Clinical trial · Interventional
Magnetic Seed Localisation of Breast Cancers
Safety and Feasibility Study of Magnetic Seed Markers to Localise Breast Cancers for Surgical Excision
NCT02635737CI-TRIAL-00049470SentimarkcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single site, single arm, unblinded safety and feasibility cohort study investigating the use of magnetic marker seeds to localise breast tumours.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentimark | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentimark device placement
- description
- Sentimark device placed in women having mastectomy surgery
- interventionNames
- Device: Sentimark
Primary outcomes (1)
- measure
- Migration of Sentimark Device
- timeFrame
- 1-4 weeks from placement
- description
- Migration of the device\>10mm between mammograms, clip position \>40mm from target lesion
Secondary outcomes (5)
- measure
- Accuracy of Initial Placement
- timeFrame
- within 60 minutes of seed placement
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.