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NCT01808417 · ClinicalTrials.gov registry record · Phase 1
NIR-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer
A Phase 1 study of Esophageal Cancer, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT01808417: Completed Phase 1 study of Esophageal Cancer, sponsored by Dana-Farber Cancer Institute.
NCT01808417 is a Phase 1 study of Esophageal Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 10 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01808417, a Phase 1 study of Esophageal Cancer, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is a Phase I clinical trial. Phase I clinical trials test the feasibility and safety of an investigational technique or drug. 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 further studies. "Investigational" means that this drug, ICG, is approved by the FDA for other imaging uses, but not for lymphatic mapping using NIR light. Its use for following lymphatic pathways from tumors in the human body is still being studied and research doctors are trying to find out more about it. It also means that the FDA has not approved ICG mapping for your type of cancer. ICG is a dye and is approved for testing liver function and measuring blood flow from the heart. This drug has been used in studies to map lymphatic pathways in lung cancer and breast cancer and information from those other research studies suggests that this dye may help to identify lymph nodes associated with your esophageal tumor in this research study. ICG can be detected within the body using special near-infrared light cameras. In this research study, the investigators are looking at how easily ICG can get to the first lymph node (called the sentinel lymph node or SLN) associated with your esophageal tumor and whether the investigators can see the path of the ICG and the respective SLN using a near infrared camera.
Primary Outcome
To determine the feasibility of real-time intraoperative NIR lymphatic mapping with concurrent identification of the sentinel lymph node in esophageal cancer using indocyanine green
Conditions Studied
Interventions
- DRUG Near Infrared Imaging
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-06-21 |
| Est. Completion | 2015-04-07 |
| Phase | Phase 1 |
What the finished NCT01808417 record still lists
NCT01808417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Esophageal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Near Infrared Imaging is the first listed.
NCT01808417 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01808417 about?
NCT01808417 is a clinical study titled "NIR-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer". This research study is a Phase I clinical trial. Phase I clinical trials test the feasibility and safety of an investigational technique or drug. This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to u...
What is the current status of trial NCT01808417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-06-21. Estimated completion is 2015-04-07.
What conditions does trial NCT01808417 study?
This clinical trial studies the following conditions: Esophageal Cancer.
What interventions are being tested in trial NCT01808417?
The interventions under investigation include: Near Infrared Imaging (DRUG).
Who is sponsoring clinical trial NCT01808417?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01808417 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01808417's enrollment target sits among peer trials
10 121st of 123 higher than 2 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Cancer 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.
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