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

NCT01468649 | Completed Early Phase 1

• 1 other identifier: 2007P000431
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Sentinel Lymph Node Mapping; Intraoperative Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  One Day (day 1)

Study Arms (1)

Breast Cancer SLN Mapping

EXPERIMENTAL

Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.

Device: NIR Imaging with FLARE and Mini-FLARE Imaging System

Interventions

NIR Imaging with FLARE and Mini-FLARE Imaging System DEVICE

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.

Also known as: Fluorescence assisted imaging

Breast Cancer SLN Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Brigham and Women's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John V. Frangioni, M.D., Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: November 9, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

US (1)