Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John V. Frangioni, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00721370
First received: July 18, 2008
Last updated: February 14, 2013
Last verified: February 2013

July 18, 2008
February 14, 2013
July 2008
January 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00721370 on ClinicalTrials.gov Archive Site
Identify sentinel lymph nodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer
Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer

Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
Device: NIR imaging system
Optical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics.
Experimental: 1
Patients imaged using ICG:HSA and NIR imaging system
Intervention: Device: NIR imaging system
Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Löwik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.

Exclusion Criteria:

  • Pregnant women,
  • Significant renal, cardiac, or pulmonary disease,
  • History of iodine allergy.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721370
2007P-000431
No
John V. Frangioni, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: John V Frangioni, MD, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP