NCT06024213

A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.

French, Prospective, Post-marketing Study to Describe the Use, Detection Performance and Safety Profile of Infracyanine® (Indocyanine Green) for Breast Cancer Patients Undergoing a Sentinel Lymph Node (SLN) Biopsy.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: BTG International Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer. The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery. The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye). The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye. The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Sentinel lymph node identification	Intervention description: Intraoperative identification of sentinel lymph node
DRUG	indocyanine green	Intervention description: indocyanine green (5 to 10 mg \[ie, 2 to 4 mL of a 2.5 mg/mL solution\]) administered by periareolar or peritumoural route
DRUG	methylene blue	1%), 2-5 mL administered by periareolar or peritumoural route
DRUG	Technetium (99mTc)	(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route

Timeline

• Start date: 2023-06-06
• Primary completion: 2023-11-06
• Completion: 2023-12-19
• First posted: 2023-09-06
• Last updated: 2024-05-10

Locations

6 sites across 1 country: France