A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.
- Conditions
- Breast Cancer
- Registration Number
- NCT06024213
- Lead Sponsor
- BTG International Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sentinel lymph node detection rate Time of Surgery Rate of detection of at least one sentinel lymph node by indocyanine green
- Secondary Outcome Measures
Name Time Method Serious adverse events From time of surgery up to 6 weeks post-surgery Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
Changes in vital signs From time of surgery up to 6 weeks post-surgery Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate
Weight At visit 1 (pre-operative consultation) Patient weight
Comorbidities At visit 1 (pre-operative consultation) Comorbidities of interest
Tumour laterality At visit 1 (pre-operative consultation) Tumour laterality
Detection equipment Time of surgery Equipment used for detection of sentinel lymph node
Number of sentinel lymph nodes detected - blue dye Time of surgery Number of sentinel lymph nodes detected (by blue dye) per patient
Number of sentinel lymph nodes detected - 99mTc Time of surgery Number of sentinel lymph nodes detected (by 99mTc) per patient
BMI At visit 1 (pre-operative consultation) Patient BMI
Tumour size At visit 1 (pre-operative consultation) Tumour size
Tumour quadrant At visit 1 (pre-operative consultation) Tumour quadrant
Indocyanine green dose Time of surgery Dose of indocyanine green
Injection site Time of surgery Description of injection site
Route of injection Time of surgery Route of injection (periareolar or peritumoural)
Time from injection to visualization Time of surgery Time from injection to visualization of first sentinel lymph node
Number of sentinel lymph nodes detected - indocyanine green Time of surgery Number of sentinel lymph nodes detected (by indocyanine green) per patient
Height At visit 1 (pre-operative consultation) Patient height
Prior excisional surgery At visit 1 (pre-operative consultation) Prior excisional surgery on the breast
Surgery type planned At visit 1 (pre-operative consultation) Type of breast surgery planned
Histological type At visit 1 (pre-operative consultation) Tumour histological type
Number of injection sites Time of surgery Number of injection sites
Number of sentinel lymph node biopsies performed Time of surgery Number of sentinel lymph node biopsies performed
Time from injection to end of biopsy Time of surgery Time from injection to end of biopsy procedure
Adverse events From time of surgery up to 6 weeks post-surgery Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
Menopause status At visit 1 (pre-operative consultation) Menopause status
Tumour grade At visit 1 (pre-operative consultation) Tumour grade
Tumour stage At visit 1 (pre-operative consultation) Tumour stage
Hormone receptor status At visit 1 (pre-operative consultation) Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)
Detection method Time of surgery Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)
Indocyanine green volume Time of surgery Volume of indocyanine green
Number of sentinel lymph nodes detected Time of surgery Number of sentinel lymph nodes detected (by all detection methods) per patient
Age At visit 1 (pre-operative consultation) Patient age
Trial Locations
- Locations (6)
Hôpital Européen Georges-Pompidou Paris
🇫🇷Paris, Île-de-France, France
Institut de Cancérologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de Saint-Etienne
🇫🇷Saint-Etienne, Loire, France
CH Annecy-Genevois
🇫🇷Annecy, Epagny Metz-Tessy, Haute-Savoie, France
Institut Bergonié
🇫🇷Bordeaux, Gironde, France
CHU de Lille
🇫🇷Lille, Nord, France