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Brief Title: A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.
Official Title: 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.
Study ID: NCT06024213
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
CH Annecy-Genevois, Annecy, Epagny Metz-Tessy, Haute-Savoie, France
Institut Bergonié, Bordeaux, Gironde, France
CHU de Saint-Etienne, Saint-Etienne, Loire, France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de Lille, Lille, Nord, France
Hôpital Européen Georges-Pompidou Paris, Paris, Île-de-France, France
Name: Céline Chauleur, MD
Affiliation: CHU de Saint-Etienne
Role: STUDY_CHAIR