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Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma

13. září 2026 aktualizováno: Washington University School of Medicine

Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma

This observational study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy. ICG is a fluorescent dye given into a vein during surgery. Patients receive ICG as part of their clinical care, independently of whether they participate in this study. The study plans to enroll 25 adults undergoing surgery for confirmed or strongly suspected cancer. Researchers will record near-infrared images obtained during clinical ICG use, compare them with tissue pathology, and measure the strength, timing, and duration of fluorescence. The research analysis will not guide clinical or surgical decisions. Participants will be followed through 24 hours after surgery.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This single-center, prospective observational cohort study evaluates the relationship between first-window ICG fluorescence and the biopsy-defined extent of head and neck squamous cell carcinoma during surgical resection. The decision to use intraoperative ICG is made as part of clinical care independently of study enrollment. Research activities consist of recording fluorescence imaging data and correlating those data with standard-of-care histopathology. First-window imaging captures fluorescence during initial dye perfusion after intraoperative administration.

After tumor exposure and standard white-light inspection, the ICG regimen described for observation consists of a 2 mg intravenous bolus followed by a saline flush. Completion of the flush defines T0. Continuous near-infrared video is recorded from T0 through 3 minutes after T0 using an ICG-compatible imaging system. The described regimen includes three boluses totaling 6 mg ICG; actual doses and administration times are documented. Clinical dosing decisions remain with the treating team independently of study participation. Further dosing may be held for hypersensitivity or hemodynamic instability, and imaging may be stopped if it interferes with surgical workflow.

Biopsies are obtained according to standard clinical practice, and their locations relative to fluorescence are documented. The research correlation of fluorescence with histopathology does not direct clinical or surgical decisions. Fluorescence measurements are compared with histopathology to estimate tumor-to-background ratio, sensitivity, specificity, time to fluorescence onset, time to peak contrast, and dose-dependent fluorescence dynamics. De-identified imaging data will be analyzed by the University of Alabama at Birmingham Department of Otolaryngology.

Participants are followed through 24 hours after surgery. Adverse events considered at least possibly related to ICG are collected from the first dose through 24 hours after surgery.

Typ studie

Pozorovací

Zápis (Odhadovaný)

25

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Bharat Panuganti, MD, FACS
  • Telefonní číslo: 314-362-7522
  • E-mail: bharatp@wustl.edu

Studijní místa

  • Spojené státy
    • Missouri
      • St Louis, Missouri, Spojené státy, 63110
        • Washington University School of Medicine
        • Kontakt:
          • Bharat Panuganti, MD, FACS
          • Telefonní číslo: 314-362-7522
          • E-mail: bharatp@wustl.edu
        • Vrchní vyšetřovatel:
          • Bharat Panuganti, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Adults with histologically or cytologically confirmed, or strong clinical suspicion of, head and neck squamous cell carcinoma who are preparing to undergo surgical resection at Washington University School of Medicine / Barnes-Jewish Hospital.

Popis

Inclusion Criteria:

  • Histologically or cytologically confirmed, or strong clinical suspicion contingent on standard of care pre-operative assessment, of head and neck squamous cell carcinoma (HNSCC), preparing to undergo surgical resection.
  • At least 18 years of age.
  • The effects of ICG on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to surgery and for 1 week after surgery. Should a woman become pregnant or suspect she is pregnant during this time or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG, sodium iodide, or other agents used in the study.
  • Thyroid radioactive uptake study within 1 week of ICG administration.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day of surgery.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Head and neck surgical resection cohort
Adults undergoing resection for confirmed or strongly suspected HNSCC who receive intraoperative ICG with NIR imaging as part of clinical care independently of study enrollment. Research activities include recording imaging data and comparing fluorescence with routine tissue pathology. The research analysis does not guide clinical or surgical decisions.
Lék: Indocyanine green
Clinical exposure of interest: intraoperative ICG. The regimen described for observation is three 2 mg IV boluses, each followed by a saline flush, totaling 6 mg. Actual doses and times are recorded; clinical dosing is determined independently of study participation.
Ostatní jména:
  • ICG
Postup: Near-infrared fluorescence imaging
Continuous video from completion of the saline flush (T0) through 3 minutes after each bolus, using an FDA-cleared ICG-compatible NIR imaging system.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Tumor-to-background ratio (TBR)
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
TBR is calculated as the mean fluorescence intensity (MFI) within a region of interest (ROI) drawn over pathology-confirmed tumor tissue divided by the MFI within an ROI drawn over adjacent clinically normal tissue, as measured on intraoperative near-infrared fluorescence imaging. The mean TBR with 95% confidence intervals will be reported.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Defined as the proportion of histopathologically confirmed tumor regions correctly identified as fluorescent. A standardized fluorescence ratio (SFR) threshold, determined by receiver operating characteristic (ROC) analysis using the maximum Youden's J index, will be used to classify tissue as fluorescent-positive or fluorescent-negative.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Specificity of Indocyanine Green (ICG) fluorescence for tumor detection
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Defined as the proportion of histopathologically confirmed normal tissue regions correctly identified as non-fluorescent. A standardized fluorescence ratio (SFR) threshold, determined by receiver operating characteristic (ROC) analysis using the maximum Youden's J index, will be used to classify tissue as fluorescent-positive or fluorescent-negative.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Time to first detectable tumor fluorescence
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Time in seconds from completion of the saline flush after intravenous ICG administration (T0) to the first visible tumor fluorescence above background on serial intraoperative NIR imaging.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Time to peak tumor-to-background ratio
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day
Time in seconds from completion of the saline flush after intravenous ICG administration (T0) to the first visible tumor fluorescence above background on serial intraoperative NIR imaging.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day
Association between ICG dose and tumor-to-background ratio
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Association between administered ICG dose, expressed in mg/kg after adjustment for body weight, and tumor-to-background ratio (TBR), evaluated using Pearson or Spearman correlation. TBR is the mean fluorescence intensity in pathology-confirmed tumor divided by that in adjacent clinically normal tissue.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Association between ICG dose and fluorescence washout kinetics
Časové okno: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Relationship between administered ICG dose and the decline in tumor-to-background ratio over time, characterized by fitting exponential decay models to serial TBR measurements.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Washington University School of Medicine

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bharat Panuganti, MD, FACS, Washington University School of Medicine

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

31. října 2026

Primární dokončení (Odhadovaný)

30. dubna 2028

Dokončení studie (Odhadovaný)

30. dubna 2028

Termíny zápisu do studia

První předloženo

13. září 2026

První předloženo, které splnilo kritéria kontroly kvality

13. září 2026

První zveřejněno (Aktuální)

17. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 202608227

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

produkt vyrobený a vyvážený z USA

Ne

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