---
title: IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER
nct_id: NCT01790399
overall_status: UNKNOWN
phase: NA
sponsor: Centre Oscar Lambret
study_type: INTERVENTIONAL
primary_condition: BREAST CANCER
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01790399.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01790399"
ct_last_update_post_date: 2014-03-06
last_seen_at: "2026-05-12T06:36:57.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

**Official Title:** IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY

**NCT ID:** [NCT01790399](https://clinicaltrials.gov/study/NCT01790399)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 115
- **Lead Sponsor:** Centre Oscar Lambret
- **Collaborators:** Sysmex America, Inc.
- **Conditions:** BREAST CANCER
- **Start Date:** 2013-01
- **Completion Date:** 2014-07
- **CT.gov Last Update:** 2014-03-06

## Brief Summary

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

## Detailed Description

* Identification of Sentinel node(s)

  1. Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery
  2. Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye
  3. Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon
* Detection of Sentinel node(s)

  1. Step 1: probe SentiMag ® (study)
  2. Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard)
* Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown)
* After the procedure:

Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique.

NB: In case of synchronous bilateral cancer, 2 records are possible

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Identification of sentinel node(s)** (EXPERIMENTAL)

## Interventions

- **Excision of sentinel node(s)** (PROCEDURE) — Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)

## Primary Outcomes

- **Sentinel node(s)detected with new technical** _(time frame: The day of surgery)_ — Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)

## Secondary Outcomes

- **Detected node(s) for each method(standard and new)** _(time frame: The day of surgery)_

## Locations (4)

- Centre Oscar Lambret, Lille, France
- Centre Eugène Marquis, Rennes, France
- Institut Claudius Regaud, Toulouse, France
- Centre Alexis Vautrin, Vandœuvre-lès-Nancy, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre oscar lambret|lille||france` — added _(2026-05-12)_
- `locations.centre eugène marquis|rennes||france` — added _(2026-05-12)_
- `locations.institut claudius regaud|toulouse||france` — added _(2026-05-12)_
- `locations.centre alexis vautrin|vandœuvre-lès-nancy||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01790399.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01790399*  
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