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NCT Number: NCT07696754

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM

Skopje, 1000, North Macedonia

Location contact

Borislav Kondov, MD

CONTACT

[email protected]

+38972539003

About this study

Accurate axillary nodal staging is central to breast cancer management. During axillary lymph node dissection, some nodal tissue-particularly in the apical/high axilla-can remain after the operating surgeon considers the dissection complete. Near-infrared fluorescence imaging with indocyanine green (ICG) can highlight nodal tissue intraoperatively. This pilot evaluates a wearable augmented-reality imaging system that displays combined color and near-infrared information, used for a brief "second-look" examination after the surgeon has declared the axillary procedure complete.

This is a prospective, single-arm pilot in patients undergoing breast cancer surgery with complete axillary lymph node dissection. After the surgeon prospectively declares the axillary procedure complete, a short additional in vivo fluorescence review of the surgical field is performed. If additional fluorescent tissue is identified, it is re-assessed under standard operating-room lighting and removed only if the surgeon judges removal safe and clinically appropriate; goggle findings do not replace standard surgical judgment. Any tissue removed at the second-look is submitted separately for histopathology, and findings are classified by tissue type and anatomic location.

The study is exploratory and is not powered to demonstrate clinical benefit; it is intended to assess feasibility, safety, and an initial clinical signal to inform a larger study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy
  • Neoadjuvant chemotherapy
  • Prior breast surgery
  • Iodine or seafood allergy
  • Indocyanine green (ICG) allergy
  • Declines or is unable to provide informed consent

Treatment and study plan

Augmented-reality ICG fluorescence second-look imaging

Device

A 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.

Primary outcomes

  1. Patient-level rate of clinically significant events (CSE)

    Time frame: From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)

    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).

Secondary outcomes

  1. Distribution of additional fluorescent findings by tissue category

    Time frame: Final histopathology (up to approximately 2 weeks after surgery)

    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).

  2. Anatomic location of additional fluorescent findings

    Time frame: Intraoperative (day of surgery)

    Anatomic location of each additional fluorescent finding, recorded as axillary level I, II, or III; interpectoral (Rotter); internal mammary; or other.

  3. Nodal stage migration

    Time frame: Final histopathology (up to approximately 2 weeks after surgery)

    Change in pathological nodal category (pN) before versus after inclusion of tissue removed at the second-look review.

  4. Added operative time for the second-look review

    Time frame: Intraoperative (day of surgery)

    Additional operative time required to perform the second-look review, in minutes.

  5. Procedure- or device-related adverse events

    Time frame: Through 30 days after surgery

    Number of participants with adverse events related to the study procedure or device.

Study contacts

Contact information is provided by the study sponsor or research team.

Borislav Kondov, MD

CONTACT

[email protected]

+38972539003

Magdalena Bogdanovska Todorovska, MD

CONTACT

[email protected]

+389709602221

Sponsors and collaborators

Lead sponsor

Ss. Cyril and Methodius University of Skopje

Other

Collaborators

  • University of Illinois at Urbana-Champaign

Registry information

Official study title

Mapping of Lymph Nodes Using Augmented-reality/Virtual-reality Goggles in Patients With Breast Cancer

Acronym: AR4SLN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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