Clinical trial · Interventional
Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer
NCT00721370CI-TRIAL-00009496completedPhase 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)
Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.
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 system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients imaged using ICG:HSA and NIR imaging system
- interventionNames
- Device: NIR imaging system
Primary outcomes (1)
- measure
- Ergonomics and function of the imaging system - verify that the imaging system does not interfere with Sentinel Lymph Node mapping procedure and can be used safely by the surgeon.
- timeFrame
- Typical 1 hour clinical procedure
Secondary outcomes (1)
- measure
- Identify sentinel lymph nodes
- timeFrame
- 1 hour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease. Exclusion Criteria: * Pregnant women, * Significant renal, cardiac, or pulmonary disease, * History of iodine allergy.
References
Publications (1)
- DERIVEDMieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1. PMID 21360250