NCT02875626

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Infracyanine	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).

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-02-01
• Completion: 2019-03-01
• First posted: 2016-08-23
• Last updated: 2019-07-05

Locations

1 site across 1 country: France