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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468649
• Other study ID #: 2007P000431
• Status: Completed
• Phase: Early Phase 1
• First received: June 30, 2011
• Last updated: March 3, 2017
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of Real-Time Intraoperative NIR Mapping	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).	One Day (day 1)
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	To evaluate the incidence of significant adverse reactions due to both NIR lymphatic mapping and indocyanine green.	One Day (day 1)