Sentinel Lymph Node Technique in Multifocal Breast Cancer

Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00417495

Acronym

IGASSU

Enrollment

216

Registered

2007-01-01

Start date

2006-03-01

Completion date

2010-08-13

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

adenocarcinoma, breast, multifocal lesions, surgery

Brief summary

The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

Detailed description

The sentinel lymph node is located preferentially by: * association of subareolar injection of technecium and blue dye * or, in case of blue dye allergy, by the subareolar injection of technecium only * or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery * This procedure is immediately follows by complete axillary dissection during breast surgery * The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.

Interventions

BEHAVIORALSentinel Lymph Node Technique

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Multifocal invasive breast cancer * At least 2 focuses (clinically and/or by mammography or ultrasound) * Proven by pre-surgical histology (on 1 focus at least) * Age \> 18 years old * Clinically negative axillary lymph nodes * No treatment before surgery * Signature of written informed consent

Exclusion criteria

* Multifocality proven after surgery * Non invasive breast cancer * Inflammatory breast cancer * Axillary lymph node * Metastatic disease * Previous homolateral breast cancer * Dementia or alterated mental status * Pregnant or lactating woman

Design outcomes

Primary

Measure	Time frame
detection rate of sentinel nodes	surgery

Secondary

Measure	Time frame
number of sentinel nodes removed	surgery
localisation of the sentinel nodes	surgery

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGIARD Sylvia, MD

Centre Oscar Lambret

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026