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AzTrials

Breast CancerNCT07683572

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

An observational study of Breast Cancer and Breast Neoplasms, run by Ss. Cyril and Methodius University of Skopje at 1 site in North Macedonia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
AR-ICG near-infrared fluorescence imaging
Type of treatment
Medical device
How many people
200 participants
Where
1 siteNorth Macedonia
Study dates
1 Jul 2026to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Borislav Kondov, MD contact

+38972539003

borislav.kondov@medf.ukim.edu.mk

Magdalena Bogdanovska Todorovska, MD contact

+389709602221

magdalena.todorovska@medf.ukim.edu.mk

North Macedonia1 site

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

    Skopje, 1000

    Borislav Kondov, MD, +38972539003, borislav.kondov@medf.ukim.edu.mk

Other trials in North Macedonia

About this study

Official title: Validation of Augmented-Reality/Virtual-Reality Goggle-Based Near-Infrared Fluorescence Imaging for Sentinel Lymph Node Detection in Patients With Breast Cancer

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.

Read the detailed description

This is a prospective observational device-validation study in patients undergoing breast cancer surgery with axillary evaluation. Augmented-reality goggle-based near-infrared fluorescence imaging with ICG is used to visualize and mark candidate sentinel lymph nodes. Intraoperative near-infrared imaging may be performed by an observer who is not the operating surgeon, solely to assess device performance; observer findings are not communicated to the operating surgeon before wound closure and do not influence the operation. All marked nodes and removed tissue undergo histopathology, which serves as the blinded reference standard. Device performance is assessed on consecutive eligible patients within defined enrollment windows; for each near-infrared imaging device, sensitivity, specificity, positive and negative predictive value, and node-level ROC analysis are estimated against final histopathology, with confidence intervals accounting for clustering of nodes within patients. The study is non-interventional: the imaging does not alter surgical management.

Being tested
AR-ICG near-infrared fluorescence imaging
Keywords
indocyanine green, near-infrared fluorescence, augmented reality, sentinel lymph node biopsy, diagnostic accuracy, medical device validation
Medical subject headings
Breast Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AR-ICG near-infrared fluorescence imagingDevice

    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.

Study groups in NCT07683572
Study groupRoleWhat they receive
Breast cancer patients undergoing surgery with AR-ICG node imagingPatients 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.
Receives: Device: AR-ICG near-infrared fluorescence imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Patient-level sentinel-node detection rate

    Proportion of patients in whom at least one sentinel lymph node is identified by AR-ICG near-infrared fluorescence imaging.

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

  2. Concordance of device-marked nodes with histopathology

    Agreement between lymph nodes marked by AR-ICG fluorescence imaging and nodal status confirmed on final histopathology.

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

  3. Per-device diagnostic performance across near-infrared imaging systems

    Sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve estimated separately for each near-infrared imaging device evaluated, using final histopathology as the reference standard, on consecutive eligible patients within defined enrollment windows.

    Measured: Through study completion (up to approximately 24 months)

  4. False-negative rate of AR-ICG fluorescence node detection

    Proportion of pathology-confirmed tumor-positive lymph nodes not identified as fluorescent by AR-ICG imaging.

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

  5. Number of candidate sentinel nodes identified per patient

    Number of candidate sentinel lymph nodes marked by AR-ICG fluorescence imaging per patient (count).

    Measured: Intraoperative (day of surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07683572
Sponsor's protocol ID
UKIM-AR-ICG-BREAST-VALID-2026
Status last verified
Jun 2026
First submitted
28 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a single-center observational device-validation study. Individual participant data are not planned to be shared. De-identified data may be made available from the principal investigator on reasonable request, subject to institutional approval.

Publications

  • 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.

    PubMed 28898379

  • 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.

    PubMed 39966355

  • 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.

    PubMed 25439688

  • 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.

    PubMed 38598571

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Breast Neoplasms, run by Ss. Cyril and Methodius University of Skopje at 1 site in North Macedonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Borislav Kondov, MD (+38972539003, borislav.kondov@medf.ukim.edu.mk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology (time frame: From surgery to final histopathology (up to ~2 weeks after surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07683572, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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