Breast Cancer, Breast Neoplasms, Lymphatic Metastasis, Sentinel Lymph Node
Conditions
Keywords
indocyanine green, near-infrared fluorescence, augmented reality, sentinel lymph node biopsy, diagnostic accuracy, medical device validation
Brief summary
This study evaluates how accurately augmented-reality goggles with indocyanine green (ICG) near-infrared fluorescence can identify sentinel (first-draining) lymph nodes during breast cancer surgery. The goggles and ICG signal are used to mark candidate sentinel nodes, and an additional observer may record near-infrared images during the operation for device-performance assessment. These imaging findings do not change the surgical procedure. The candidate nodes and all removed tissue are examined by histopathology, which serves as the reference standard. Two hundred patients undergoing breast cancer surgery will take part. The study measures how well the goggle-based imaging detects nodes that contain cancer, compared with final pathology.
Detailed description
This is a prospective observational device-validation study in patients undergoing breast cancer surgery with axillary evaluation. Augmented-reality goggle-based near-infrared fluorescence imaging with ICG is used to visualize and mark candidate sentinel lymph nodes. Intraoperative near-infrared imaging may be performed by an observer who is not the operating surgeon, solely to assess device performance; observer findings are not communicated to the operating surgeon before wound closure and do not influence the operation. All marked nodes and removed tissue undergo histopathology, which serves as the blinded reference standard. Device performance is assessed on consecutive eligible patients within defined enrollment windows; for each near-infrared imaging device, sensitivity, specificity, positive and negative predictive value, and node-level ROC analysis are estimated against final histopathology, with confidence intervals accounting for clustering of nodes within patients. The study is non-interventional: the imaging does not alter surgical management.
Interventions
DEVICEAR-ICG near-infrared fluorescence imaging
Augmented-reality goggle-based near-infrared fluorescence imaging with indocyanine green (ICG), used to visualize and mark candidate sentinel lymph nodes during breast cancer surgery. Intraoperative near-infrared imaging may also be recorded by an observer for device-performance assessment. Imaging does not alter surgical management; histopathology serves as the reference standard.
Sponsors
Ss. Cyril and Methodius University of Skopje
University of Illinois at Urbana-Champaign
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven breast cancer * Age 18 years or older * Undergoing breast cancer surgery with sentinel lymph node evaluation and/or axillary lymph node dissection * Provides written informed consent
Exclusion criteria
* Pregnancy * Neoadjuvant chemotherapy * Prior breast surgery * Iodine or seafood allergy * Indocyanine green (ICG) allergy * Declines or is unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology | From surgery to final histopathology (up to ~2 weeks after surgery) | Sensitivity, specificity, positive and negative predictive value, and area under the ROC curve for goggle-based near-infrared fluorescence detection of tumor-positive lymph nodes, using final histopathology as the reference standard, with confidence intervals accounting for clustering of nodes within patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level sentinel-node detection rate | Final histopathology (up to approximately 2 weeks after surgery) | Proportion of patients in whom at least one sentinel lymph node is identified by AR-ICG near-infrared fluorescence imaging. |
| Concordance of device-marked nodes with histopathology | Final histopathology (up to approximately 2 weeks after surgery) | Agreement between lymph nodes marked by AR-ICG fluorescence imaging and nodal status confirmed on final histopathology. |
| Per-device diagnostic performance across near-infrared imaging systems | Through study completion (up to approximately 24 months) | Sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve estimated separately for each near-infrared imaging device evaluated, using final histopathology as the reference standard, on consecutive eligible patients within defined enrollment windows. |
| False-negative rate of AR-ICG fluorescence node detection | Final histopathology (up to approximately 2 weeks after surgery) | Proportion of pathology-confirmed tumor-positive lymph nodes not identified as fluorescent by AR-ICG imaging. |
| Number of candidate sentinel nodes identified per patient | Intraoperative (day of surgery) | Number of candidate sentinel lymph nodes marked by AR-ICG fluorescence imaging per patient (count). |
Countries
North Macedonia
Contacts
CONTACTBorislav Kondov, MD
CONTACTMagdalena Bogdanovska Todorovska, MD
Outcome results
None listed