Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Infracyanine

Study type: Interventional

Funder types: Other

Identifiers

NCT02875626

FLUOBREAST

Details and patient eligibility

About

This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.

Full description

Visits:

Screening:

Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.

Intervention:

In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).

The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.

• All radioactive nodes and / or fluorescent will be deleted
• Reports of anatomy fluorescent SN and / or hot

Next visit:

The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female age > 18 years
2. Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
3. Diagnosis confirmed by biopsy
4. Breast cancer extended in situ
5. First surgical treatment

Exclusion criteria

1. Neoadjuvant chemotherapy or hormone therapy.
2. Multicentric tumor
3. Pregnant patient
4. Ongoing participation in another clinical trial with an investigational drug

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Infracyanine

Experimental group

Description:

In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).

Treatment:

Drug: Infracyanine