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

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.

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Sentinel lymph node identification; Drug: indocyanine green; Drug: methylene blue; Drug: Technetium (99mTc)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jennie Molland; Phone Number: +44 7805 354 134; Email: jennie.molland@serb.com

Study Locations

• France
  • Epagny Metz-Tessy, Haute-Savoie
    • Annecy, Epagny Metz-Tessy, Haute-Savoie, France, 74370
      • Recruiting
      • CH Annecy-Genevois
      • Contact: Didier Tardif; Phone Number: +447805354134; Email: jennie.molland@serb.com
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Recruiting
      • Institut Bergonie
      • Contact: Sophie Auriol-Leizagoyen; Phone Number: +447805354134; Email: jennie.molland@serb.com
  • Loire
    • Saint-Etienne, Loire, France, 42100 France
      • Recruiting
      • Chu de Saint-Etienne
      • Contact: Institut de Cancérologie de Lorraine
  • Meurthe-et-Moselle
    • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
      • Recruiting
      • Institut de Cancérologie de Lorraine
      • Contact: Frédéric Marchal; Phone Number: 44 7805 354 134; Email: jennie.molland@serb.com
  • Nord
    • Lille, Nord, France, 59000
      • Recruiting
      • CHU de Lille
      • Contact: Yohan Kerbage; Phone Number: 44 7805 354 134; Email: jennie.molland@serb.com
  • Île-de-France
    • Paris, Île-de-France, France, 75015
      • Recruiting
      • Hôpital Européen Georges-Pompidou Paris
      • Contact: Meriem Koual

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sentinel lymph node detection rate by obesity status	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	Time of surgery
Sentinel lymph node detection rate in early-stage breast cancer	Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer	Time of surgery
Sentinel lymph node detection rate by indocyanine green dose	Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose	Time of surgery
Sentinel lymph node detection rate by injection route	Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route	Time of surgery

Collaborators and Investigators

• Sponsor: BTG International Inc.
• Collaborators: Iqvia Pty Ltd
• Investigators: Study Chair: Céline Chauleur, MD, Chu de Saint-Etienne

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: sentinel lymph node biopsy; indocyanine green biopsy; fluorescence blue dye; technetium99
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: PR024-CLN-pro101