Clinical trial · Interventional
Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions
Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green
- 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 is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
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 |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blue Dyes | Other | — | UNRESOLVED |
| Cardio-Green | Other | — | UNRESOLVED |
| Gamma probe | Device | — | UNRESOLVED |
| PDE Imaging system | Device | — | UNRESOLVED |
| Quest near-infrared (NIR) Imaging system | Device | — | UNRESOLVED |
| Smart Goggle | Device | — | UNRESOLVED |
| SPY Elite Imaging system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Integrated Imaging Goggles
- description
- Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes.
- interventionNames
- Device: Smart Goggle
- Other: Cardio-Green
- Device: SPY Elite Imaging system
- Device: Quest near-infrared (NIR) Imaging system
- Device: PDE Imaging system
- Device: Gamma probe
- Other: Blue Dyes
Primary outcomes (1)
- measure
- Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.
- timeFrame
- At the end of the procedure, about 50 minutes
- description
- Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with at least 1 lesion of tumor of the breast * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Subjects who have been treated with radiation therapy on the chest. * Has had previous sentinel lymph node biopsy * Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
References
Publications (0)
Data not yet available