Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer

NCT ID: NCT00721370

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

1

Patients imaged using ICG:HSA and NIR imaging system

Group Type: EXPERIMENTAL

NIR imaging system

Intervention Type: DEVICE

Optical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics.

Interventions

NIR imaging system

Optical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John V. Frangioni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John V Frangioni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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, Lowik 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.

Reference Type: DERIVED

PMID: 21360250 (View on PubMed)

Related Links

http://www.frangionilab.org

Website of the study principal investigator with detailed information about related work.

Other Identifiers

2007P-000431

Identifier Type: -

Identifier Source: org_study_id