Clinical trial · Interventional
IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER
IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
NCT01790399CI-TRIAL-00013959SENTIMAGunknownN/AClinicalTrials.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)
The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study
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 |
|---|---|---|---|
| Excision of sentinel node(s) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Identification of sentinel node(s)
- interventionNames
- Procedure: Excision of sentinel node(s)
Primary outcomes (1)
- measure
- Sentinel node(s)detected with new technical
- timeFrame
- The day of surgery
- description
- Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
Secondary outcomes (1)
- measure
- Detected node(s) for each method(standard and new)
- timeFrame
- The day of surgery
- description
- Proportion of detected nodes for each method(standard and new)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type * cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone ) * Age greater than or equal to 18 * Reporting of breast surgery and axillary staging of sentinel lymph node * Using effective contraception (BHCG negative) * Patient affiliated with a health insurance * Consent signed by the patient Exclusion Criteria: * T3 or T4 tumors (\> 5 cm, cutaneous or muscle inflammation or cancer) * Presence of a clinically suspicious axillary adenopathy or imaging * Tumors bifocal or multifocal known before Surgery * History of breast surgery or axillary * Patient metastatic * Patient with a cons-indication anesthesia and / or surgery * Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to Patent blue dye in centers where it is commonly used * Patient can not receive a radioactive isotope to the sentinel lymph node resection * Allergy radioactive product * Chronic iron overload * Pacemaker or other implantable device in the chest wall * Failure to submit to medical study for geographical, social or psychological * Patient deprived of liberty or under guardianship * Pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.