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Intervention description: Intraoperative identification of sentinel lymph node

Sentinel lymph node identification

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

indocyanine green

1%), 2-5 mL administered by periareolar or peritumoural route

methylene blue

(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route

Technetium (99mTc)

Céline Chauleur, MD

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.

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.

Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients

Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer

Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose

Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route

Rate of detection of at least one sentinel lymph node by indocyanine green

Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)

Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)

Route of injection (periareolar or peritumoural)

Equipment used for detection of sentinel lymph node

Number of sentinel lymph node biopsies performed

Time from injection to visualization of first sentinel lymph node

Time from injection to end of biopsy procedure

Number of sentinel lymph nodes detected (by all detection methods) per patient

Number of sentinel lymph nodes detected (by indocyanine green) per patient

Number of sentinel lymph nodes detected (by blue dye) per patient

Number of sentinel lymph nodes detected (by 99mTc) per patient

Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA

Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA

Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.	NCT06024213	Breast Cancer	Sentinel lymph ... indocyanine gre... methylene blue Technetium (99m...	18 Years -	BTG International Inc.
A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.	NCT06024213	Breast Cancer	Sentinel lymph ... indocyanine gre... methylene blue Technetium (99m...	18 Years -	BTG International Inc.

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