Status:

COMPLETED

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

Lead Sponsor:

BTG International Inc.

Collaborating Sponsors:

Iqvia Pty Ltd

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

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 f...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 6 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 19 2023

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT06024213

Start Date

June 6 2023

End Date

December 19 2023

Last Update

May 10 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

CH Annecy-Genevois

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

2

Institut Bergonié

Bordeaux, Gironde, France, 33000

3

Institut de Cancérologie de Lorraine

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

4

CHU de Lille

Lille, Nord, France, 59000