INFLUENCE II - a Pilot Study for Implementation Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively FLUorEsceNt Imaging Using indoCyaninE Green: a Pilot Study for Implementation
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy
• Preoperative axillary ultrasound to confirm clinical node-negative status
• Indication for breast cancer surgery with SLNB via axillar incision
• Written informed consent according to national regulations
Locations
Other Locations
Italy
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
RECRUITING
Peschiera Del Garda
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Active_comparator: 99mTc
radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)
Experimental: ICG
indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)
Related Therapeutic Areas
Sponsors
Leads: Casa di Cura Dott. Pederzoli