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Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer

NCT01468649 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-03-07

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

  • John V. Frangioni, M.D., Ph.D. · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468649 on ClinicalTrials.gov