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NCT01121718 · ClinicalTrials.gov registry record · Phase 1
NIR-Guided Sentinel Lymph Node Mapping in Melanoma
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01121718: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01121718 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121718, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for future studies. ICG is a dye which has been in use since the 50s, and is approved for testing liver function and measuring blood flow from the heart. It has been used in studies to map lymphatic pathways in lung and breast cancer and information from those studies suggest it may help identify lymph nodes associated with melanoma. ICG can be detected within the body using near-infrared light cameras. In this study the investigators are looking at how easily ICG can get to the first lymph node (sentinel lymph node \[SLN\]) associated with melanoma, whether the investigators can see the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it does provide a small amount of radiation. This study will compare the investigators results to the standard procedure.
Primary Outcome
To determine the feasibility of real-time intraoperative NIR lymphatic mapping with concurrent identification of the sentinel lymph node in human melanoma using indocyanine green.
Interventions
- DRUG ICG Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01121718 record still lists
NCT01121718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which ICG Intervention is the first listed.
NCT01121718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01121718 about?
NCT01121718 is a clinical study titled "NIR-Guided Sentinel Lymph Node Mapping in Melanoma". This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for future studies. ICG is a dye which has been in use since the 50s, and is approved for testing liver function and measuring blood flow from...
What is the current status of trial NCT01121718?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-09. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01121718?
The interventions under investigation include: ICG Intervention (DRUG).
Who is sponsoring clinical trial NCT01121718?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01121718's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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