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

6 juillet 2026 mis à jour par: Borislav Kondov, Ss. Cyril and Methodius University of Skopje

Mapping of Lymph Nodes Using Augmented-reality/Virtual-reality Goggles in Patients With Breast Cancer

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Accurate axillary nodal staging is central to breast cancer management. During axillary lymph node dissection, some nodal tissue-particularly in the apical/high axilla-can remain after the operating surgeon considers the dissection complete. Near-infrared fluorescence imaging with indocyanine green (ICG) can highlight nodal tissue intraoperatively. This pilot evaluates a wearable augmented-reality imaging system that displays combined color and near-infrared information, used for a brief "second-look" examination after the surgeon has declared the axillary procedure complete.

This is a prospective, single-arm pilot in patients undergoing breast cancer surgery with complete axillary lymph node dissection. After the surgeon prospectively declares the axillary procedure complete, a short additional in vivo fluorescence review of the surgical field is performed. If additional fluorescent tissue is identified, it is re-assessed under standard operating-room lighting and removed only if the surgeon judges removal safe and clinically appropriate; goggle findings do not replace standard surgical judgment. Any tissue removed at the second-look is submitted separately for histopathology, and findings are classified by tissue type and anatomic location.

The study is exploratory and is not powered to demonstrate clinical benefit; it is intended to assess feasibility, safety, and an initial clinical signal to inform a larger study.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient-level rate of clinically significant events (CSE)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Distribution of additional fluorescent findings by tissue category
Délai: 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
Délai: 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
Délai: Final histopathology (up to approximately 2 weeks after surgery)
Change in pathological nodal category (pN) before versus after inclusion of tissue removed at the second-look review.
Final histopathology (up to approximately 2 weeks after surgery)
Added operative time for the second-look review
Délai: 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
Délai: Through 30 days after surgery
Number of participants with adverse events related to the study procedure or device.
Through 30 days after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ss. Cyril and Methodius University of Skopje

Collaborateurs

University of Illinois at Urbana-Champaign

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 juillet 2026

Achèvement primaire (Estimé)

1 juillet 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

28 juin 2026

Première soumission répondant aux critères de contrôle qualité

6 juillet 2026

Première publication (Réel)

10 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UKIM-AR-ICG-BREAST-2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

This is a small single-center pilot 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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