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Brief Title: Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
Official Title: Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer
Study ID: NCT01468649
Brief Summary: The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imaging.
Detailed Description: Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study. Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the time of SLN mapping, the patient will be injected with indocyanine green dye (ICG). Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location. The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm the radioactivity and NIR fluorescence signal in each after resection.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Name: John V. Frangioni, M.D., Ph.D.
Affiliation: Beth Israel Deaconess Medical Center
Role: PRINCIPAL_INVESTIGATOR