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Spots Global Cancer Trial Database for Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Contact Details

Name: John V. Frangioni, M.D., Ph.D.

Affiliation: Beth Israel Deaconess Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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