RecruitingNot ApplicableNCT07441733

Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients

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


Sponsor

Casa di Cura Dott. Pederzoli

Enrollment

40 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the use of a fluorescent dye called indocyanine green (ICG) to help surgeons more accurately identify and remove sentinel lymph nodes (the first lymph nodes that cancer might spread to) during breast cancer surgery. Better detection of these nodes can help guide treatment decisions. **You may be eligible if...** - You have been diagnosed with breast cancer (DCIS or invasive cancer, stage T1–T3) by biopsy - Imaging confirms no cancer spread to the armpit lymph nodes - You are scheduled for breast cancer surgery that includes sentinel lymph node biopsy through an armpit incision - You are 18 or older - You have provided written consent **You may NOT be eligible if...** - You are under 18 years old - Your sentinel lymph node biopsy will be performed through a mastectomy incision - You have a known allergy to ICG, intravenous contrast, or iodine - You have previously had armpit lymph nodes removed - You are pregnant or breastfeeding - There are personal, social, or geographic factors that would prevent you from following the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREICG used as a tracer for sentinel lymph node

ICG used as a tracer for sentinel lymph node instead of technetium 99

PROCEDUREtechnetium 99 used as a tracer for sentinel lymph node

technetium 99 used as a tracer for sentinel lymph node instead of ICG


Locations(1)

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, Italy

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NCT07441733


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