Device Validation of Augmented-Reality ICG Fluorescence Imaging for Sentinel Lymph Node Detection in Breast Cancer

NCT07683572 | Not Yet Recruiting

• 1 other identifier: UKIM-AR-ICG-BREAST-VALID-2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates how accurately augmented-reality goggles with indocyanine green (ICG) near-infrared fluorescence can identify sentinel (first-draining) lymph nodes during breast cancer surgery. The goggles and ICG signal are used to mark candidate sentinel nodes, and an additional observer may record near-infrared images during the operation for device-performance assessment. These imaging findings do not change the surgical procedure. The candidate nodes and all removed tissue are examined by histopathology, which serves as the reference standard. Two hundred patients undergoing breast cancer surgery will take part. The study measures how well the goggle-based imaging detects nodes that contain cancer, compared with final pathology.

Conditions

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

Keywords

indocyanine green; near-infrared fluorescence; augmented reality; sentinel lymph node biopsy; diagnostic accuracy; medical device validation

Outcome Measures

Primary Outcomes (1)

• Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology

  Sensitivity, specificity, positive and negative predictive value, and area under the ROC curve for goggle-based near-infrared fluorescence detection of tumor-positive lymph nodes, using final histopathology as the reference standard, with confidence intervals accounting for clustering of nodes within patients.

  From surgery to final histopathology (up to ~2 weeks after surgery)

Secondary Outcomes (5)

• Patient-level sentinel-node detection rate

  Final histopathology (up to approximately 2 weeks after surgery)

• Concordance of device-marked nodes with histopathology

  Final histopathology (up to approximately 2 weeks after surgery)

• Per-device diagnostic performance across near-infrared imaging systems

  Through study completion (up to approximately 24 months)

• False-negative rate of AR-ICG fluorescence node detection

  Final histopathology (up to approximately 2 weeks after surgery)

• Number of candidate sentinel nodes identified per patient

  Intraoperative (day of surgery)

Study Arms (1)

Breast cancer patients undergoing surgery with AR-ICG node imaging

Patients undergoing breast cancer surgery in whom AR-ICG goggle-based near-infrared imaging is used to mark candidate sentinel nodes, with optional observer near-infrared imaging for device-performance assessment; histopathology is the reference standard.

Device: AR-ICG near-infrared fluorescence imaging

Interventions

AR-ICG near-infrared fluorescence imaging DEVICE

Augmented-reality goggle-based near-infrared fluorescence imaging with indocyanine green (ICG), used to visualize and mark candidate sentinel lymph nodes during breast cancer surgery. Intraoperative near-infrared imaging may also be recorded by an observer for device-performance assessment. Imaging does not alter surgical management; histopathology serves as the reference standard.

Breast cancer patients undergoing surgery with AR-ICG node imaging

Eligibility Criteria

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

Study Population

Patients with histologically proven breast cancer undergoing surgery with axillary lymph node evaluation at the participating center, enrolled consecutively.

You may qualify if:

• Histologically proven breast cancer
• Age 18 years or older
• Undergoing breast cancer surgery with sentinel lymph node evaluation and/or 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

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

Study Sites (1)

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

Skopje, 1000, North Macedonia

Location

Related Publications (4)

• 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

• 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

• 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

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Principal Investigator

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)