Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented-reality ICG fluorescence second-look imaging.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Neoplasms, Sentinel Lymph Node, Lymphatic Metastasis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- North Macedonia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mapping of Lymph Nodes Using Augmented-reality/Virtual-reality Goggles in Patients With Breast Cancer
Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (5)
- Distribution of additional fluorescent findings by tissue category [Time frame: Final histopathology (up to approximately 2 weeks after surgery)]
- Anatomic location of additional fluorescent findings [Time frame: Intraoperative (day of surgery)]
- Nodal stage migration [Time frame: Final histopathology (up to approximately 2 weeks after surgery)]
- Added operative time for the second-look review [Time frame: Intraoperative (day of surgery)]
- Procedure- or device-related adverse events [Time frame: Through 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
North Macedonia · 1 center
- University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM — Skopje
Publications
- 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 Trialis PMID 38598571
- 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. PMID 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 PMID 25439688
- 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- PMID 28898379
Identifiers
NCT: NCT07696754 · UKIM-AR-ICG-BREAST-2026