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NCT01468649 · ClinicalTrials.gov registry record · Early Phase 1
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
A Early Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT01468649: Completed Early Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01468649 is a Early Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468649, a Early Phase 1 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DEVICE NIR Imaging with FLARE and Mini-FLARE Imaging System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
What the finished NCT01468649 record still lists
NCT01468649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which NIR Imaging with FLARE and Mini-FLARE Imaging System is the first listed.
NCT01468649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468649 about?
NCT01468649 is a clinical study titled "Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer". 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.
What is the current status of trial NCT01468649?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2011-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01468649?
The interventions under investigation include: NIR Imaging with FLARE and Mini-FLARE Imaging System (DEVICE).
Who is sponsoring clinical trial NCT01468649?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468649's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,467 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
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