NRI-Guided Sentinel Lymph-Node Mapping for Esophageal Cancer

Status: Recruiting
Phase: Phase 0
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01808417 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-179

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Yolanda Colson, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Inclusion Criteria: - Suspected or confirmed esophageal cancer - Deemed an appropriate surgical candidate with consent for esophagectomy and lymphadenectomy or staging lymphadenectomy by their thoracic surgeon Exclusion Criteria: - Patients who choose not to proceed with surgery - History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including thos patients with a history of iodide or seafood allergy - Women who are pregnant or breastfeeding
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