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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 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 26 participants.
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.
Interventions
- DRUG ICG Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01121718
The ClinicalTrials.gov registry entry for NCT01121718 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ICG Intervention is the first listed.
NCT01121718 reports 0 study locations.
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.
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