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

NCT06024213 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2024-05-10

No results posted yet for this study

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

Interventions

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

DRUG

methylene blue

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

DRUG

Technetium (99mTc)

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

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • BTG International Inc.

    lead OTHER

Principal Investigators

  • Céline Chauleur, MD · CHU de Saint-Etienne

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2023-11-06
Completion
2023-12-19

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024213 on ClinicalTrials.gov