Clinical trial NCT06024213: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: sentinel lymph node biopsy
indocyanine green biopsy
fluorescence blue dye
technetium99
Lead sponsor: BTG International Inc.
Sponsor class: OTHER
Collaborators: name: Iqvia Pty Ltd
First posted: 2023-09-06
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted at French hospitals involved in the management of female patients with breast cancer where indocyanine green is used in routine practice. Patients will be enrolled from approximately 5 sites in metropolitan France.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sentinel lymph node detection rate
timeFrame: Time of Surgery
Secondary outcomes:
measure: Age
timeFrame: At visit 1 (pre-operative consultation)
measure: Height
timeFrame: At visit 1 (pre-operative consultation)
measure: Weight
timeFrame: At visit 1 (pre-operative consultation)
measure: BMI
timeFrame: At visit 1 (pre-operative consultation)
measure: Comorbidities
timeFrame: At visit 1 (pre-operative consultation)
measure: Menopause status
timeFrame: At visit 1 (pre-operative consultation)
measure: Prior excisional surgery
timeFrame: At visit 1 (pre-operative consultation)
measure: Surgery type planned
timeFrame: At visit 1 (pre-operative consultation)
measure: Tumour size
timeFrame: At visit 1 (pre-operative consultation)
measure: Tumour grade
timeFrame: At visit 1 (pre-operative consultation)
measure: Tumour stage
timeFrame: At visit 1 (pre-operative consultation)
measure: Histological type
timeFrame: At visit 1 (pre-operative consultation)
measure: Hormone receptor status
timeFrame: At visit 1 (pre-operative consultation)
measure: Tumour laterality
timeFrame: At visit 1 (pre-operative consultation)
measure: Tumour quadrant
timeFrame: At visit 1 (pre-operative consultation)
measure: Detection method
timeFrame: Time of surgery
measure: Indocyanine green dose
timeFrame: Time of surgery
measure: Indocyanine green volume
timeFrame: Time of surgery
measure: Injection site
timeFrame: Time of surgery
measure: Number of injection sites
timeFrame: Time of surgery
measure: Route of injection
timeFrame: Time of surgery
measure: Detection equipment
timeFrame: Time of surgery
measure: Number of sentinel lymph node biopsies performed
timeFrame: Time of surgery
measure: Time from injection to visualization
timeFrame: Time of surgery
measure: Time from injection to end of biopsy
timeFrame: Time of surgery
measure: Number of sentinel lymph nodes detected
timeFrame: Time of surgery
measure: Number of sentinel lymph nodes detected - indocyanine green
timeFrame: Time of surgery
measure: Number of sentinel lymph nodes detected - blue dye
timeFrame: Time of surgery
measure: Number of sentinel lymph nodes detected - 99mTc
timeFrame: Time of surgery
measure: Adverse events
timeFrame: From time of surgery up to 6 weeks post-surgery
measure: Serious adverse events
timeFrame: From time of surgery up to 6 weeks post-surgery
measure: Changes in vital signs
timeFrame: From time of surgery up to 6 weeks post-surgery
Other outcomes:
measure: Sentinel lymph node detection rate by obesity status
timeFrame: Time of surgery
measure: Sentinel lymph node detection rate in early-stage breast cancer
timeFrame: Time of surgery
measure: Sentinel lymph node detection rate by indocyanine green dose
timeFrame: Time of surgery
measure: Sentinel lymph node detection rate by injection route
timeFrame: Time of surgery
Locations:
city: Annecy
country: France
facility: CH Annecy-Genevois
state: Epagny Metz-Tessy, Haute-Savoie
city: Bordeaux
country: France
facility: Institut Bergonié
state: Gironde
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
state: Loire
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHU de Lille
state: Nord
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou Paris
state: Île-de-France
Study officials:
affiliation: CHU de Saint-Etienne
name: Céline Chauleur, MD
role: STUDY_CHAIR
References:
citation: Vermersch C, Raia-Barjat T, Chapelle C, Lima S, Chauleur C. Randomized comparison between indocyanine green fluorescence plus 99mtechnetium and 99mtechnetium alone methods for sentinel lymph node biopsy in breast cancer. Sci Rep. 2019 May 6;9(1):6943. doi: 10.1038/s41598-019-43473-3.
citation: Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017 Nov 2;15(1):196. doi: 10.1186/s12957-017-1264-7.
citation: Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211.
citation: Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer. Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15.