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

NCT06024213 | Completed

• 1 other identifier: PR024-CLN-pro101
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

sentinel lymph node biopsy; indocyanine green biopsy; fluorescence blue dye; technetium99

Outcome Measures

Primary Outcomes (1)

• Sentinel lymph node detection rate

  Rate of detection of at least one sentinel lymph node by indocyanine green

  Time of Surgery

Secondary Outcomes (32)

• Age

  At visit 1 (pre-operative consultation)

• Height

  At visit 1 (pre-operative consultation)

• Weight

  At visit 1 (pre-operative consultation)

• BMI

  At visit 1 (pre-operative consultation)

• Comorbidities

  At visit 1 (pre-operative consultation)

Other Outcomes (4)

• Sentinel lymph node detection rate by obesity status

  Time of surgery

• Sentinel lymph node detection rate in early-stage breast cancer

  Time of surgery

• Sentinel lymph node detection rate by indocyanine green dose

  Time of surgery

Interventions

Sentinel lymph node identification PROCEDURE

Intervention description: Intraoperative identification of sentinel lymph node

indocyanine green DRUG

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 DRUG

1%), 2-5 mL administered by periareolar or peritumoural route

Technetium (99mTc) DRUG

(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTG International Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (6)

CH Annecy-Genevois

Annecy, Epagny Metz-Tessy, Haute-Savoie, 74370, France

Location

Institut Bergonié

Bordeaux, Gironde, 33000, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

CHU de Lille

Lille, Nord, 59000, France

Location

CHU de Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42100 France, France

Location

Hôpital Européen Georges-Pompidou Paris

Paris, Île-de-France Region, 75015, France

Location

Related Publications (4)

• 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.

  PMID: 31061432 BACKGROUND

• 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.

  PMID: 29096643 BACKGROUND

• 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.

  PMID: 16110291 BACKGROUND

• 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.

  PMID: 26275781 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green; Methylene Blue; Technetium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Study Officials

• Céline Chauleur, MD

  CHU de Saint-Etienne

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: June 6, 2023
• Primary Completion: November 6, 2023
• Study Completion: December 19, 2023
• Last Updated: May 10, 2024

Record last verified: 2023-09

Locations

FR (6)