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

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Céline Chauleur, MD

Affiliation: CHU de Saint-Etienne

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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