Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02316795 · ClinicalTrials.gov registry record · Early Phase 1
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT02316795: Completed Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT02316795 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316795, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.
Primary Outcome
After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols. Identification of the SLN via fluorescence imag
Interventions
- PROCEDURE Sentinel lymph node biopsy
- DEVICE Goggle-based device with light-emitting diodes (LED)
- DRUG Indocynanine Green
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-12 |
| Phase | Early Phase 1 |
What the finished NCT02316795 record still lists
NCT02316795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Sentinel lymph node biopsy is the first listed.
NCT02316795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02316795 about?
NCT02316795 is a clinical study titled "Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma". The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommende...
What is the current status of trial NCT02316795?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2014-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02316795?
The interventions under investigation include: Sentinel lymph node biopsy (PROCEDURE), Goggle-based device with light-emitting diodes (LED) (DEVICE), Indocynanine Green (DRUG).
Who is sponsoring clinical trial NCT02316795?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02316795's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia