Clinical trial

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.

Name

PR024-CLN-pro101

Description

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.

Trial arms

Trial start

2023-06-06

Estimated PCD

2023-11-06

Trial end

2023-12-19

Status

Completed

Treatment

Sentinel lymph node identification

Intervention description: Intraoperative identification of sentinel lymph node

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

Size

101

Primary endpoint

Sentinel lymph node detection rate

Time of 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 101, 'type': 'ACTUAL'}}

Updated at

2024-05-10

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product