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Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer

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.

Inclusion Criteria:

- Participant must have histologically confirmed breast cancer and be deemed an
appropriate surgical candidate with consent for a sentinel lymph node mapping by
their oncologic surgeon.

- 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:

- Participants who choose not to proceed with sentinel lymph node biopsy.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity of Real-Time Intraoperative NIR Mapping

Outcome Description:

To determine the sensitivity of real-time intraoperative NIR lymphatic mapping in the identification of the sentinel lymph node in human breast cancer as compared to the standard of care, Technicium 99 (Tc-99).

Outcome Time Frame:

One Day (day 1)

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Sentinel Lymph Node Mapping
  • Intraoperative Imaging
  • Breast Neoplasms



Dana Farber Cancer InstituteBoston, Massachusetts  02115