NIR-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer
Status:
Completed
Trial end date:
2015-04-07
Target enrollment:
Participant gender:
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.