This study tests whether special imaging goggles can help surgeons find lymph nodes that may be left behind during breast cancer surgery. The goggles show a fluorescent dye (indocyanine green, ICG) that is given during the operation and collects in lymph nodes.
In breast cancer surgery, the surgeon removes lymph nodes from the armpit (axilla) to check whether the cancer has spread. Some nodes can be difficult to see and may remain after the surgeon believes the removal is complete. This study looks at whether the goggles can reveal such remaining nodes after the surgeon has declared the axillary surgery finished.
Thirty patients having breast cancer surgery with removal of the axillary lymph nodes will take part. After the surgeon states the planned removal is complete, the surgeon will briefly re-examine the area using the goggles and the ICG signal. If additional glowing tissue is seen, the surgeon will decide-using normal surgical judgment-whether it is safe and appropriate to remove it. Any tissue removed this way is examined under the microscope to determine whether it is a lymph node and whether it contains cancer.
The study measures how often this additional examination finds cancer-containing nodes that would otherwise have remained, where these nodes are located, whether the finding changes the cancer stage, and how much extra time the examination takes. The study also records any side effects. The results will help determine whether this approach should be studied in a larger trial.
Histologically proven breast cancer
Age 18 years or older
Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection
Provides written informed consent
Pregnancy
Neoadjuvant chemotherapy
Prior breast surgery
Iodine or seafood allergy
Single group
Augmented-reality ICG fluorescence second-look imaging
DeviceA wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.
Patient-level rate of clinically significant events (CSE)
Proportion of patients with at least one clinically significant event (CSE). A CSE is defined as additional fluorescent tissue identified at the second-look review after the surgeon's declared completion of the axillary dissection, not previously planned for removal, removed after re-assessment under standard lighting, and confirmed on final histopathology to be a lymph node containing tumor (isolated tumor cells, micrometastasis, or macrometastasis).
Distribution of additional fluorescent findings by tissue category
Number of additional fluorescent findings classified on histopathology as tumor-positive lymph node, tumor-negative lymph node, or non-nodal tissue (e.g., fibro-adipose tissue or dye leakage).
Anatomic location of additional fluorescent findings
Anatomic location of each additional fluorescent finding, recorded as axillary level I, II, or III; interpectoral (Rotter); internal mammary; or other.
Nodal stage migration
Change in pathological nodal category (pN) before versus after inclusion of tissue removed at the second-look review.
Added operative time for the second-look review
Additional operative time required to perform the second-look review, in minutes.
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Ss. Cyril and Methodius University of Skopje
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborator
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