NCT01993576

ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.

Detailed description

Primary objective: Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent). Secondary objectives: Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist. Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).

Conditions

• Breast Cancer.

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-11-25
• Last updated: 2014-10-15

Locations

1 site across 1 country: Belgium