Clinical trial · Observational
Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.
Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node in Patients With Breast Cancer.
- 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)
The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.
Conditions
Conditions (2)
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 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Indocyanine green
- description
- Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Achieve Intraoperative fluorescence images by Near-Infrared I ( NIR-I ) fluorescence imaging instrument.
- interventionNames
- Drug: Indocyanine green
Primary outcomes (1)
- measure
- Diagnosis of lymph node metastasis
- timeFrame
- Participants will be followed for the duration of hospital stay, an expected average of 3 months
- description
- The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18-70 years female. * The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer. * No clinical examination of suspicious axillary lymph node-positive. * Preoperative clinical or radiologic evidence without distant metastases (M0). * The patient has good compliance with the planned protocol during the study and signed informed consent. Exclusion Criteria: * Pregnancy, breastfeeding. * Allergy to ICG. * Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer. * Psychiatric or cognitive impairment.
References
Publications (0)
Data not yet available