Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICG used as a tracer for sentinel lymph node, technetium 99 used as a tracer for sentinel lymph node.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.
Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
Interventions
- Procedure ICG used as a tracer for sentinel lymph node
ICG used as a tracer for sentinel lymph node instead of technetium 99 - Procedure technetium 99 used as a tracer for sentinel lymph node
technetium 99 used as a tracer for sentinel lymph node instead of ICG
Primary outcome measures
- Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (6)
- Percentage of SLNs that has 99mTc uptake/ is fluorescent [Time frame: through study completion, an average of 1 year]
- Detection time [Time frame: through study completion, an average of 1 year]
- Total operative time [Time frame: through study completion, an average of 1 year]
- Number of complications and (serious) adverse events [Time frame: through study completion, an average of 1 year]
- loco regional recurrence after 1 year follow-up [Time frame: through study completion, an average of 1 year]
- The pathology of SLNs identified [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients < 18 years old.
- Indication for breast cancer surgery with SLNB via mastectomy incision
- Known allergy for ICG, intravenous contrast or iodine
- History of axillary lymph node dissection
- Pregnancy or breast-feeding
- Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda
Identifiers
NCT: NCT07441733 · 418CET