Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSs. Cyril and Methodius University of Skopje

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnancy

Neoadjuvant chemotherapy

Prior breast surgery

Iodine or seafood allergy

Trial design

Treatments tested in this trial

  • Augmented-reality ICG fluorescence second-look imaging

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ss. Cyril and Methodius University of Skopje

Lead sponsor

University of Illinois at Urbana-Champaign

Collaborator