Device Validation of Augmented-Reality ICG Fluorescence Imaging for Sentinel Lymph Node Detection in Breast Cancer
28. juni 2026 oppdatert av: Borislav Kondov, Ss. Cyril and Methodius University of Skopje
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Borislav Kondov, MD
- Telefonnummer: +38972539003
- E-post: borislav.kondov@medf.ukim.edu.mk
Studer Kontakt Backup
- Navn: Magdalena Bogdanovska Todorovska, MD
- Telefonnummer: +389709602221
- E-post: magdalena.todorovska@medf.ukim.edu.mk
Studiesteder
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Skopje, Nord-Makedonia, 1000
- University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM
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Ta kontakt med:
- Borislav Kondov, MD
- Telefonnummer: +38972539003
- E-post: borislav.kondov@medf.ukim.edu.mk
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients with histologically proven breast cancer undergoing surgery with axillary lymph node evaluation at the participating center, enrolled consecutively.
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Neoadjuvant chemotherapy
- Prior breast surgery
- Iodine or seafood allergy
- Indocyanine green (ICG) allergy
- Declines or is unable to provide informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology
Tidsramme: From surgery to final histopathology (up to ~2 weeks after surgery)
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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.
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From surgery to final histopathology (up to ~2 weeks after surgery)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient-level sentinel-node detection rate
Tidsramme: Final histopathology (up to approximately 2 weeks after surgery)
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Proportion of patients in whom at least one sentinel lymph node is identified by AR-ICG near-infrared fluorescence imaging.
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Final histopathology (up to approximately 2 weeks after surgery)
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Concordance of device-marked nodes with histopathology
Tidsramme: Final histopathology (up to approximately 2 weeks after surgery)
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Agreement between lymph nodes marked by AR-ICG fluorescence imaging and nodal status confirmed on final histopathology.
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Final histopathology (up to approximately 2 weeks after surgery)
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Per-device diagnostic performance across near-infrared imaging systems
Tidsramme: Through study completion (up to approximately 24 months)
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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.
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Through study completion (up to approximately 24 months)
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False-negative rate of AR-ICG fluorescence node detection
Tidsramme: Final histopathology (up to approximately 2 weeks after surgery)
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Proportion of pathology-confirmed tumor-positive lymph nodes not identified as fluorescent by AR-ICG imaging.
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Final histopathology (up to approximately 2 weeks after surgery)
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Number of candidate sentinel nodes identified per patient
Tidsramme: Intraoperative (day of surgery)
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Number of candidate sentinel lymph nodes marked by AR-ICG fluorescence imaging per patient (count).
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Intraoperative (day of surgery)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
28. juni 2026
Først innsendt som oppfylte QC-kriteriene
28. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UKIM-AR-ICG-BREAST-VALID-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .