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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Sentinel lymph node identification
* Drug: indocyanine green
* Drug: methylene blue
* Drug: Technetium (99mTc)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged ≥18 years Undergoing breast cancer surgery with an indication for sentinel lymph node biopsy Receiving Infracyanine® (indocyanine green; alone or in combination with blue dye or 99mTc) for intraoperative identification of sentinel lymph node according to the Summary of Product Characteristics Exclusion Criteria: Male Pregnant or nursing female Previous allergy to indocyanine green or to any excipients Already included in a surgical trial Patient opposed to collection and processing of their data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel lymph node detection rate | Rate of detection of at least one sentinel lymph node by indocyanine green | Time of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Patient age | At visit 1 (pre-operative consultation) | 
| Height | Patient height | At visit 1 (pre-operative consultation) | 
| Weight | Patient weight | At visit 1 (pre-operative consultation) | 
| BMI | Patient BMI | At visit 1 (pre-operative consultation) | 
| Comorbidities | Comorbidities of interest | At visit 1 (pre-operative consultation) | 
| Menopause status | Menopause status | At visit 1 (pre-operative consultation) | 
| Prior excisional surgery | Prior excisional surgery on the breast | At visit 1 (pre-operative consultation) | 
| Surgery type planned | Type of breast surgery planned | At visit 1 (pre-operative consultation) | 
| Tumour size | Tumour size | At visit 1 (pre-operative consultation) | 
| Tumour grade | Tumour grade | At visit 1 (pre-operative consultation) | 
| Tumour stage | Tumour stage | At visit 1 (pre-operative consultation) | 
| Histological type | Tumour histological type | At visit 1 (pre-operative consultation) | 
| Hormone receptor status | Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status) | At visit 1 (pre-operative consultation) | 
| Tumour laterality | Tumour laterality | At visit 1 (pre-operative consultation) | 
| Tumour quadrant | Tumour quadrant | 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 of surgery | 
| Indocyanine green dose | Dose of indocyanine green | Time of surgery | 
| Indocyanine green volume | Volume of indocyanine green | Time of surgery | 
| Injection site | Description of injection site | Time of surgery | 
| Number of injection sites | Number of injection sites | Time of surgery | 
| Route of injection | Route of injection (periareolar or peritumoural) | Time of surgery | 
| Detection equipment | Equipment used for detection of sentinel lymph node | Time of surgery | 
| Number of sentinel lymph node biopsies performed | Number of sentinel lymph node biopsies performed | Time of surgery | 
| Time from injection to visualization | Time from injection to visualization of first sentinel lymph node | Time of surgery | 
| Time from injection to end of biopsy | Time from injection to end of biopsy procedure | Time of surgery | 
| Number of sentinel lymph nodes detected | Number of sentinel lymph nodes detected (by all detection methods) per patient | Time of surgery | 
| Number of sentinel lymph nodes detected - indocyanine green | Number of sentinel lymph nodes detected (by indocyanine green) per patient | Time of surgery | 
| Number of sentinel lymph nodes detected - blue dye | Number of sentinel lymph nodes detected (by blue dye) per patient | Time of surgery | 
| Number of sentinel lymph nodes detected - 99mTc | Number of sentinel lymph nodes detected (by 99mTc) per patient | Time of surgery | 
| Adverse events | Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA | 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 | 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 | From time of surgery up to 6 weeks post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sentinel lymph node biopsy, indocyanine green biopsy, fluorescence blue dye, technetium99