Clinical trial · Interventional
The Efficacy of Sentimag in Detection of Sentinel Node Biopsy
SMART Study: Sentimag Along With Routine Technique in Detection of Sentinel Node Biopsy
- 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)
The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping. The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB.
Conditions
Conditions (2)
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 |
| Sentinel Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentimag Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Standard Procedure plus use of sentimag
- description
- Detection of the nodes carried out using the gamma probe and also the sentimag - all patients receive both diagnostic interventions
- interventionNames
- Device: Sentimag Device
Primary outcomes (1)
- measure
- Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique
- timeFrame
- 6 Months
Secondary outcomes (4)
- measure
- Detection rate per node
- timeFrame
- 6 Months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with primary breast cancer scheduled for Sentinel node biopsy; * Patients who are clinically and radiologically node negative;. * Patients aged ≥18 years at time of consent * Patients are able and willing to give informed consent * Ability and willingness to undertake all scheduled visits and assessments Exclusion Criteria: * Patients who are currently Pregnantcy or lactatingon; * Patients with metastatic cancer; * Subject has a known hypersensitivity to blue dye; * Patients with intolerance or hypersensitivity to iron oxide or dextran compounds;, or to Sienna+ * Patients who have iron overload disease; * Patients who has a pacemaker or other implantable device in the chest wall or shoulder; * Previous axilla surgery, or impaired lymphatic function * Subject is deprived of liberty or under guardianship * Subject is indicated or scheduled for post-operative MRI investigation of the breast
References
Publications (0)
Data not yet available