Clinical trial · Interventional
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
NCT07441733CI-TRIAL-00111050INFLUENCE IIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG used as a tracer for sentinel lymph node | Procedure | — | UNRESOLVED |
| technetium 99 used as a tracer for sentinel lymph node | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 99mTc
- description
- radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)
- interventionNames
- Procedure: technetium 99 used as a tracer for sentinel lymph node
- type
- EXPERIMENTAL
- label
- ICG
- description
- indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)
- interventionNames
- Procedure: ICG used as a tracer for sentinel lymph node
Primary outcomes (1)
- measure
- Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.