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

NCT07696754 | Not Yet Recruiting

• 1 other identifier: UKIM-AR-ICG-BREAST-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms; Breast Cancer; Sentinel Lymph Node; Lymphatic Metastasis

Keywords

indocyanine green; near-infrared fluorescence; fluorescence-guided surgery; augmented reality; axillary lymph node dissection; residual nodal disease; sentinel lymph node; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (5)

• Distribution of additional fluorescent findings by tissue category

  Final histopathology (up to approximately 2 weeks after surgery)

• Anatomic location of additional fluorescent findings

  Intraoperative (day of surgery)

• Nodal stage migration

  Final histopathology (up to approximately 2 weeks after surgery)

• Added operative time for the second-look review

  Intraoperative (day of surgery)

• Procedure- or device-related adverse events

  Through 30 days after surgery

Study Arms (1)

AR-ICG Second-Look

EXPERIMENTAL

After the operating surgeon declares the axillary lymph node dissection complete, a brief augmented-reality ICG near-infrared fluorescence re-examination of the surgical field is performed. Additional fluorescent tissue is re-assessed under standard lighting and removed only if the surgeon judges removal safe and clinically appropriate; removed tissue undergoes separate histopathology.

Device: Augmented-reality ICG fluorescence second-look imaging

Interventions

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.

AR-ICG Second-Look

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: collaborator
• Ss. Cyril and Methodius University of Skopje: lead

Study Sites (1)

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

Skopje, 1000, North Macedonia

Location

Related Publications (4)

• de Boniface J, Filtenborg Tvedskov T, Ryden L, Szulkin R, Reimer T, Kuhn T, Kontos M, Gentilini OD, Olofsson Bagge R, Sund M, Lundstedt D, Appelgren M, Ahlgren J, Norenstedt S, Celebioglu F, Sackey H, Scheel Andersen I, Hoyer U, Nyman PF, Vikhe Patil E, Wieslander E, Dahl Nissen H, Alkner S, Andersson Y, Offersen BV, Bergkvist L, Frisell J, Christiansen P; SENOMAC Trialists' Group; SENOMAC Trialists' Group. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med. 2024 Apr 4;390(13):1163-1175. doi: 10.1056/NEJMoa2313487.

  PMID: 38598571 RESULT

• Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther. 2025 Feb 19;10(1):49. doi: 10.1038/s41392-024-02108-4.

  PMID: 39966355 RESULT

• Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.

  PMID: 25439688 RESULT

• Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

  PMID: 28898379 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Borislav Kondov, MD

CONTACT

+38972539003; borislav.kondov@medf.ukim.edu.mk

Magdalena Bogdanovska Todorovska, MD

CONTACT

+389709602221; magdalena.todorovska@medf.ukim.edu.mk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Principal Investigator

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 10, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)