Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00721370|
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: NIR imaging system||Phase 1|
The standard of care in breast cancer surgery includes identification and assessment of the sentinel lymph node (SLN). At the present time, SLN mapping utilizes a gamma ray-emitting radiotracer and/or a blue dye. Radiotracers provide sensitive detection of SLNs, but require involvement of a nuclear medicine physician, vary widely in transit time depending on the agent employed, can be difficult to localize with a handheld gamma probe, and expose both patient and caregivers to ionizing radiation. Blue dyes, such as isosulfan blue, cannot be seen easily through skin and fat, but can aid in definitive identification of the SLN when the handheld gamma probe gives ambiguous results. Finally, the learning curve associated with expertise in the SLN procedure is quite long using currently available techniques.
In this 12-patient pilot study, we are testing a new intraoperative imaging system that we developed for image-guided surgery. The imaging system uses invisible, near-infrared (NIR) light to visualize lymphatic flow and to identify the SLN. The imaging system makes no contact with the patient and can display surgical anatomy simultaneously with NIR fluorescence.
All patients will receive the standard of care for SLN mapping, namely technetium-99m sulfur colloid lymphoscintigraphy. In addition, patients will be injected with indocyanine green (ICG) diluted in human serum albumin (HSA). ICG is already FDA approved for other indications and is used in this study at 400-fold to 2000-fold lower than the typical clinical dose. Dilution into HSA improves the brightness of ICG by over 3-fold, making it an excellent tracer for lymphatic flow.
The purpose of this pilot study is to determine whether the ergonomics of the imaging system interfere with typical clinical workflow during breast cancer surgery. A secondary goal is to optimize the imaging parameters (light levels, exposure time, etc.) associated with identification of the SLN.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer|
|Study Start Date :||July 2008|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
Patients imaged using ICG:HSA and NIR imaging system
Device: NIR imaging system
Optical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics.
- Ergonomics and function of the imaging system - verify that the imaging system does not interfere with Sentinel Lymph Node mapping procedure and can be used safely by the surgeon. [ Time Frame: Typical 1 hour clinical procedure ]
- Identify sentinel lymph nodes [ Time Frame: 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721370
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||John V Frangioni, MD, PhD||Beth Israel Deaconess Medical Center|