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.
Study Type
OBSERVATIONAL
Enrollment
101
Intervention description: Intraoperative identification of sentinel lymph node
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
1%), 2-5 mL administered by periareolar or peritumoural route
(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route
CH Annecy-Genevois
Annecy, Epagny Metz-Tessy, Haute-Savoie, France
Institut Bergonié
Bordeaux, Gironde, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de Lille
Lille, Nord, France
CHU de Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Hôpital Européen Georges-Pompidou Paris
Paris, Île-de-France Region, France
Sentinel lymph node detection rate
Rate of detection of at least one sentinel lymph node by indocyanine green
Time frame: Time of Surgery
Age
Patient age
Time frame: At visit 1 (pre-operative consultation)
Height
Patient height
Time frame: At visit 1 (pre-operative consultation)
Weight
Patient weight
Time frame: At visit 1 (pre-operative consultation)
BMI
Patient BMI
Time frame: At visit 1 (pre-operative consultation)
Comorbidities
Comorbidities of interest
Time frame: At visit 1 (pre-operative consultation)
Menopause status
Menopause status
Time frame: At visit 1 (pre-operative consultation)
Prior excisional surgery
Prior excisional surgery on the breast
Time frame: At visit 1 (pre-operative consultation)
Surgery type planned
Type of breast surgery planned
Time frame: At visit 1 (pre-operative consultation)
Tumour size
Tumour size
Time frame: At visit 1 (pre-operative consultation)
Tumour grade
Tumour grade
Time frame: At visit 1 (pre-operative consultation)
Tumour stage
Tumour stage
Time frame: At visit 1 (pre-operative consultation)
Histological type
Tumour histological type
Time frame: At visit 1 (pre-operative consultation)
Hormone receptor status
Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)
Time frame: At visit 1 (pre-operative consultation)
Tumour laterality
Tumour laterality
Time frame: At visit 1 (pre-operative consultation)
Tumour quadrant
Tumour quadrant
Time frame: At visit 1 (pre-operative consultation)
Detection method
Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)
Time frame: Time of surgery
Indocyanine green dose
Dose of indocyanine green
Time frame: Time of surgery
Indocyanine green volume
Volume of indocyanine green
Time frame: Time of surgery
Injection site
Description of injection site
Time frame: Time of surgery
Number of injection sites
Number of injection sites
Time frame: Time of surgery
Route of injection
Route of injection (periareolar or peritumoural)
Time frame: Time of surgery
Detection equipment
Equipment used for detection of sentinel lymph node
Time frame: Time of surgery
Number of sentinel lymph node biopsies performed
Number of sentinel lymph node biopsies performed
Time frame: Time of surgery
Time from injection to visualization
Time from injection to visualization of first sentinel lymph node
Time frame: Time of surgery
Time from injection to end of biopsy
Time from injection to end of biopsy procedure
Time frame: Time of surgery
Number of sentinel lymph nodes detected
Number of sentinel lymph nodes detected (by all detection methods) per patient
Time frame: Time of surgery
Number of sentinel lymph nodes detected - indocyanine green
Number of sentinel lymph nodes detected (by indocyanine green) per patient
Time frame: Time of surgery
Number of sentinel lymph nodes detected - blue dye
Number of sentinel lymph nodes detected (by blue dye) per patient
Time frame: Time of surgery
Number of sentinel lymph nodes detected - 99mTc
Number of sentinel lymph nodes detected (by 99mTc) per patient
Time frame: Time of surgery
Adverse events
Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
Time frame: From time of surgery up to 6 weeks post-surgery
Serious adverse events
Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
Time frame: From time of surgery up to 6 weeks post-surgery
Changes in vital signs
Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate
Time frame: From time of surgery up to 6 weeks post-surgery
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