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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 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02316795
The ClinicalTrials.gov registry entry for NCT02316795 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sentinel lymph node biopsy is the first listed.
NCT02316795 reports 0 study locations.
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.
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