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

Breast Cancer Clinical Trial

— OASIS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06024213
• Other study ID #: PR024-CLN-pro101
• Status: Completed
• Start date: June 6, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: September 2023
• Source: BTG International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 19, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• methylene blue
1%), 2-5 mL administered by periareolar or peritumoural route
• Technetium (99mTc)
(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route

Locations

Country	Name	City	State
France	CH Annecy-Genevois	Annecy	Epagny Metz-Tessy, Haute-Savoie
France	Institut Bergonié	Bordeaux	Gironde
France	CHU de Lille	Lille	Nord
France	Hôpital Européen Georges-Pompidou Paris	Paris	Île-de-France
France	CHU de Saint-Etienne	Saint-Etienne	Loire
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy	Meurthe-et-Moselle

Sponsors (2)

Lead Sponsor	Collaborator
BTG International Inc.	Iqvia Pty Ltd

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Sentinel lymph node detection rate	Rate of detection of at least one sentinel lymph node by indocyanine green	Time of Surgery
Secondary	Age	Patient age	At visit 1 (pre-operative consultation)
Secondary	Height	Patient height	At visit 1 (pre-operative consultation)
Secondary	Weight	Patient weight	At visit 1 (pre-operative consultation)
Secondary	BMI	Patient BMI	At visit 1 (pre-operative consultation)
Secondary	Comorbidities	Comorbidities of interest	At visit 1 (pre-operative consultation)
Secondary	Menopause status	Menopause status	At visit 1 (pre-operative consultation)
Secondary	Prior excisional surgery	Prior excisional surgery on the breast	At visit 1 (pre-operative consultation)
Secondary	Surgery type planned	Type of breast surgery planned	At visit 1 (pre-operative consultation)
Secondary	Tumour size	Tumour size	At visit 1 (pre-operative consultation)
Secondary	Tumour grade	Tumour grade	At visit 1 (pre-operative consultation)
Secondary	Tumour stage	Tumour stage	At visit 1 (pre-operative consultation)
Secondary	Histological type	Tumour histological type	At visit 1 (pre-operative consultation)
Secondary	Hormone receptor status	Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)	At visit 1 (pre-operative consultation)
Secondary	Tumour laterality	Tumour laterality	At visit 1 (pre-operative consultation)
Secondary	Tumour quadrant	Tumour quadrant	At visit 1 (pre-operative consultation)
Secondary	Detection method	Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)	Time of surgery
Secondary	Indocyanine green dose	Dose of indocyanine green	Time of surgery
Secondary	Indocyanine green volume	Volume of indocyanine green	Time of surgery
Secondary	Injection site	Description of injection site	Time of surgery
Secondary	Number of injection sites	Number of injection sites	Time of surgery
Secondary	Route of injection	Route of injection (periareolar or peritumoural)	Time of surgery
Secondary	Detection equipment	Equipment used for detection of sentinel lymph node	Time of surgery
Secondary	Number of sentinel lymph node biopsies performed	Number of sentinel lymph node biopsies performed	Time of surgery
Secondary	Time from injection to visualization	Time from injection to visualization of first sentinel lymph node	Time of surgery
Secondary	Time from injection to end of biopsy	Time from injection to end of biopsy procedure	Time of surgery
Secondary	Number of sentinel lymph nodes detected	Number of sentinel lymph nodes detected (by all detection methods) per patient	Time of surgery
Secondary	Number of sentinel lymph nodes detected - indocyanine green	Number of sentinel lymph nodes detected (by indocyanine green) per patient	Time of surgery
Secondary	Number of sentinel lymph nodes detected - blue dye	Number of sentinel lymph nodes detected (by blue dye) per patient	Time of surgery
Secondary	Number of sentinel lymph nodes detected - 99mTc	Number of sentinel lymph nodes detected (by 99mTc) per patient	Time of surgery
Secondary	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
Secondary	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
Secondary	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