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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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