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

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Device: NIR Imaging with FLARE and Mini-FLARE Imaging System

• Registration Number: NCT01468649
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Primary Completion: 2013-02
• Study Completion: 2013-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast Cancer SLN Mapping	NIR Imaging with FLARE and Mini-FLARE Imaging System	Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Real-Time Intraoperative NIR Mapping	One Day (day 1)	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	One Day (day 1)	To evaluate the incidence of significant adverse reactions due to both NIR lymphatic mapping and indocyanine green.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States