Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Starting soon · Not applicable
Conditions studied: Breast Cancer, Breast Neoplasms, Sentinel Lymph Node, Lymphatic Metastasis
In brief
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.
Key facts
- Study ID
- NCT07696754
- Run by
- Ss. Cyril and Methodius University of Skopje
- People needed
- 30
- Starts
- 2026-07-10
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnancy
- Neoadjuvant chemotherapy
- Prior breast surgery
- Iodine or seafood allergy
- Indocyanine green (ICG) allergy
- Declines or is unable to provide informed consent
Where it is running
- University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM — Skopje, North Macedonia
Full record on ClinicalTrials.gov
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