Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
NIR Imaging with FLARE and Mini-FLARE Imaging System
Sponsored by
About this trial
This is an interventional device feasibility trial for Breast Cancer focused on measuring Breast Cancer, Sentinel Lymph Node Mapping, Intraoperative Imaging
Eligibility Criteria
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.
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast Cancer SLN Mapping
Arm Description
Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01468649
First Posted
June 30, 2011
Last Updated
March 3, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Brigham and Women's Hospital, Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01468649
Brief Title
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
Official Title
Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Brigham and Women's Hospital, Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Sentinel Lymph Node Mapping, Intraoperative Imaging
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast Cancer SLN Mapping
Arm Type
Experimental
Arm Description
Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
Intervention Type
Device
Intervention Name(s)
NIR Imaging with FLARE and Mini-FLARE Imaging System
Other Intervention Name(s)
Fluorescence assisted imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of Real-Time Intraoperative NIR Mapping
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).
Time Frame
One Day (day 1)
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
To evaluate the incidence of significant adverse reactions due to both NIR lymphatic mapping and indocyanine green.
Time Frame
One Day (day 1)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John V. Frangioni, M.D., Ph.D.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
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