Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer (AR4SLN)

November 3, 2026 updated by: Borislav Kondov, Ss. Cyril and Methodius University of Skopje

Prospective Evaluation of Augmented-Reality ICG Fluorescence Second-Look After Axillary Lymph Node Dissection in Breast Cancer

This prospective study will enroll up to 200 patients whose clinical team has already planned an axillary lymph node dissection for breast cancer. After the surgeon completes the planned dissection and declares that no further tissue was intended for removal, a wearable augmented-reality/virtual-reality (AR/VR) system will show indocyanine-green (ICG) near-infrared fluorescence during a brief second look at the exposed surgical field. The surgeon may remove an additional fluorescent focus only after inspection under normal light and only when removal is safe and clinically appropriate. Each additional specimen will be labeled separately and examined by pathology.

The study measures the proportion of patients with an additional tumor-positive lymph node found at second look, whether such nodes change the pathological nodal category, operating time, and adverse events. The first 50 consecutive participants will form a planned descriptive device-feasibility analysis; all 200 participants will contribute to the full-cohort clinical analysis. The study does not assume that finding an additional node improves recurrence or survival.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single-center, single-arm study of 200 unique participants undergoing breast cancer surgery with axillary lymph node dissection independently indicated by the clinical team. Earlier observations from an internal, unregistered protocol are not included in this study population. The first 50 consecutive enrolled participants form a prespecified descriptive device-feasibility subset; they remain part of the full 200-patient cohort and are not a separate arm.

Before AR/VR imaging, the operating surgeon records the indication and extent of the planned axillary dissection and declares that the standard procedure and inspection are complete. A brief ICG near-infrared fluorescence second look is then performed with the wearable system within the already exposed operative field. Each additional fluorescent focus receives a unique identifier, anatomic location, image or video reference when available, and a record of whether it was visible or palpable under standard lighting. The surgeon reassesses the focus under standard lighting and removes it only when safe and clinically appropriate. Each removed focus is submitted separately for pathology. Negative scans, foci left in place, interrupted scans, device failures, and added operating time are recorded.

The primary outcome remains the patient-level rate of pathology-confirmed clinically significant events (CSE) already defined in this record: at least one additional fluorescent focus not planned for removal before the second look, removed after standard-light reassessment, and confirmed to be a lymph node containing isolated tumor cells, micrometastasis, or macrometastasis. These pathology categories are reported separately. For the clinical analysis, pathology determines the nodal category using the standard dissection specimens alone and again after adding separately labeled second-look specimens. The patient-level rate of change in pathological nodal category is reported separately from the CSE rate. Any documented change in the postoperative treatment recommendation is recorded separately from a pathology finding. Procedure- and device-related adverse events are followed for 30 days.

The first 50 participants support a descriptive report of device feasibility and workflow, including scan completion, localization of additional foci, pathology of removed foci, time, and failures. The full 200-patient cohort supports estimation of CSE yield and nodal-category change with confidence intervals. There is no conventional near-infrared camera comparator. This single-arm study does not establish an improvement in recurrence, survival, or other patient outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AR-ICG Second-Look

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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Final histopathology (up to approximately 2 weeks after surgery)
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.
Intraoperative (day of surgery)
Nodal stage migration
Time Frame: Final histopathology (up to approximately 2 weeks after surgery)

Patient-level proportion whose pathological nodal category changes when separately labeled, pathology-confirmed second-look lymph nodes are added to the standard axillary dissection specimens. Determine pN first from the standard specimens alone and then from all specimens using the applicable breast cancer staging rules. Report the direction and category of each change; report isolated tumor cells separately and do not count them as positive nodes for pN thresholds.
Final histopathology (up to approximately 2 weeks after surgery)
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.
Intraoperative (day of surgery)
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.
Through 30 days after surgery
AR/VR second-look technical completion rate
Time Frame: Intraoperative (day of surgery)

Proportion of participants in whom the planned AR/VR ICG second-look scan is completed with live fluorescence displayed over the exposed axillary field. Record incomplete scans, device failures, and the reason for each. Summarize this outcome for all enrolled participants and separately for the prespecified first 50 participants.
Intraoperative (day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ss. Cyril and Methodius University of Skopje

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UKIM-AR-ICG-BREAST-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single-center study of up to 200 participants. 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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