Clinical trial · Interventional
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer
NCT01468649CI-TRIAL-00026316completedEarly Phase 1ClinicalTrials.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)
The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imaging.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIR Imaging with FLARE and Mini-FLARE Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer SLN Mapping
- description
- Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
- interventionNames
- Device: NIR Imaging with FLARE and Mini-FLARE Imaging System
Primary outcomes (1)
- measure
- Sensitivity of Real-Time Intraoperative NIR Mapping
- timeFrame
- One Day (day 1)
- description
- To determine the sensitivity of real-time intraoperative NIR lymphatic mapping in the identification of the sentinel lymph node in human breast cancer as compared to the standard of care, Technicium 99 (Tc-99).
Secondary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must have histologically confirmed breast cancer and be deemed an appropriate surgical candidate with consent for a sentinel lymph node mapping by their oncologic surgeon. * Age minimum: 18 years. * Participant must be receiving a planned lymphoscintigraphy procedure. * Participant must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who choose not to proceed with sentinel lymph node biopsy. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy. * Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study.
References
Publications (0)
Data not yet available
No reference posted for this study.