University of Wisconsin
Madison, Wisconsin, 53705, United States
NCT Number: NCT05859971
The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov Imaging Platform, to perform sentinel lymph node biopsy.
Participants in this research study will be undergoing a sentinel lymph node biopsy as part of surgical treatment for breast cancer. Active participation will last through the post-operative visit.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Madison, Wisconsin, 53705, United States
In this study, the sentinel lymph node biopsy will be performed with radioactive tracer (technetium-99 sulfur colloid) and blue dye, which is standard of care. Decisions will be made during surgery about which lymph nodes to remove using information from the radioactive tracer and blue dye alone.
For this research, ICG fluorescence dye during participant's surgery will also be used. After anesthesia has started, the ICG fluorescence dye will be injected in the breast along at the edge of the areola in the same location as the radioactive tracer and blue dye injections. The breast and axilla will then be imaged with the Asimov Imaging Platform to look for the sentinel lymph nodes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The isosulfan blue dye injection will be performed by the participating surgeon in the operating room; as per standard of care, injection will be subareolar. Incisions will be planned based on the technetium-99m activity or at the lateral aspect of the pectoralis muscle, per usual care.
2 ml (5 mg) of ICG solution will be injected intradermally in 1-4 injection sites in the lateral areolar region. After injection, gentle manual massage will be performed for 5 minutes. ICG imaging will be obtained prior to incision. After incision is made (following standard of care procedures), the axilla will be visualized using the Asimov Platform to assess for ICG-fluorescence in sentinel lymph nodes.
Time frame: Day of operation
The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.
Time frame: Day of operation
The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence.
Time frame: Day of operation
Using the technetium-99as the gold standard, the study team will describe the number of lymph nodes that would have been missed (i.e. technetium-99 + but ICG- in removed SLN) or would have been excised unnecessarily (i.e. residual ICG-fluorescence in axilla but no residual technetium-99) if ICG-fluorescent imaging had guided the SLN.
University of Wisconsin, Madison
Other
Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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