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.
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
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Sentinel Lymph Node
- What is being tested?
- AR-ICG near-infrared fluorescence imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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.
North Macedonia1 site
University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM
Skopje, 1000
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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)
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)
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)
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)
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.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: The responsible party decided not to initiate this separate observational device-validation study. No participants were enrolled. The planned AR/VR second-look research is being pursued under NCT07696754.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ss. Cyril and Methodius University of Skopje
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Borislav Kondov, Ss. Cyril and Methodius University of Skopje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683572
- Sponsor's protocol ID
- UKIM-AR-ICG-BREAST-VALID-2026
- Status last verified
- Nov 2026
- First submitted
- 28 Jun 2026
- Last updated
- 5 Nov 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 28898379Xiong 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 39966355Donker 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 25439688de 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Augmented-Reality/Virtual-Reality Goggle-Based Near-Infrared Fluorescence Imaging for Sentinel Lymph Node Detection in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT07683572
- Acronym / sponsor ID
- UKIM-AR-ICG-BREAST-VALID-2026
- Keywords
- indocyanine green, near-infrared fluorescence, augmented reality, sentinel lymph node biopsy, diagnostic accuracy, medical device validation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The responsible party decided not to initiate this separate observational device-validation study. No participants were enrolled. The planned AR/VR second-look research is being pursued under NCT07696754.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ss. Cyril and Methodius University of SkopjeUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients undergoing surgery with AR-ICG node imaging | – | Device: AR-ICG near-infrared fluorescence 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven breast cancer undergoing surgery with axillary lymph node evaluation at the participating center, enrolled consecutively.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Neoadjuvant chemotherapy
- Prior breast surgery
- Iodine or seafood allergy
- Indocyanine green (ICG) allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR-ICG near-infrared fluorescence imagingAugmented-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. | Device | Breast cancer patients undergoing surgery with AR-ICG node imaging |
Primary outcome
Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology
Time frame: From surgery to final histopathology (up to ~2 weeks after surgery)
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.
5 secondary outcomes
Patient-level sentinel-node detection rate
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Concordance of device-marked nodes with histopathology
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Per-device diagnostic performance across near-infrared imaging systems
Time frame: Through study completion (up to approximately 24 months)
False-negative rate of AR-ICG fluorescence node detection
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Number of candidate sentinel nodes identified per patient
Time frame: Intraoperative (day of surgery)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Results publication: PubMed 28898379Giuliano 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.
- Results publication: PubMed 39966355Xiong 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.
- Results publication: PubMed 25439688Donker 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.
- Results publication: PubMed 38598571de 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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: withdrawn, as of the sponsor's last update on 5 Nov 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 Nov 2026.