Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer (AR4SLN)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Borislav Kondov, MD
- Número de teléfono: +38972539003
- Correo electrónico: borislav.kondov@medf.ukim.edu.mk
Copia de seguridad de contactos de estudio
- Nombre: Magdalena Bogdanovska Todorovska, MD
- Número de teléfono: +389709602221
- Correo electrónico: magdalena.todorovska@medf.ukim.edu.mk
Ubicaciones de estudio
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Skopje, Macedonia del norte, 1000
- University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM
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Contacto:
- Borislav Kondov, MD
- Número de teléfono: +38972539003
- Correo electrónico: borislav.kondov@medf.ukim.edu.mk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient-level rate of clinically significant events (CSE)
Periodo de tiempo: From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)
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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).
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From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Distribution of additional fluorescent findings by tissue category
Periodo de tiempo: Final histopathology (up to approximately 2 weeks after surgery)
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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).
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Final histopathology (up to approximately 2 weeks after surgery)
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Anatomic location of additional fluorescent findings
Periodo de tiempo: Intraoperative (day of surgery)
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Anatomic location of each additional fluorescent finding, recorded as axillary level I, II, or III; interpectoral (Rotter); internal mammary; or other.
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Intraoperative (day of surgery)
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Nodal stage migration
Periodo de tiempo: Final histopathology (up to approximately 2 weeks after surgery)
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Change in pathological nodal category (pN) before versus after inclusion of tissue removed at the second-look review.
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Final histopathology (up to approximately 2 weeks after surgery)
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Added operative time for the second-look review
Periodo de tiempo: Intraoperative (day of surgery)
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Additional operative time required to perform the second-look review, in minutes.
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Intraoperative (day of surgery)
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Procedure- or device-related adverse events
Periodo de tiempo: Through 30 days after surgery
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Number of participants with adverse events related to the study procedure or device.
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Through 30 days after surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UKIM-AR-ICG-BREAST-2026
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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