Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
NCT ID: NCT01468649
Last Updated: 2017-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
50 participants
INTERVENTIONAL
2011-06-30
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Breast Cancer SLN Mapping
Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
NIR Imaging with FLARE and Mini-FLARE Imaging System
A custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the injected 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.
Interventions
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NIR Imaging with FLARE and Mini-FLARE Imaging System
A custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the injected 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age minimum: 18 years.
* Participant must be receiving a planned lymphoscintigraphy procedure.
* Participant must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy.
* Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study.
18 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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John V. Frangioni
Principal Investigator
Principal Investigators
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John V. Frangioni, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2007P000431
Identifier Type: -
Identifier Source: org_study_id
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