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

13 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

25

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Bharat Panuganti, MD, FACS
  • Número de telefone: 314-362-7522
  • E-mail: bharatp@wustl.edu

Locais de estudo

  • Estados Unidos
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
        • Contato:
          • Bharat Panuganti, MD, FACS
          • Número de telefone: 314-362-7522
          • E-mail: bharatp@wustl.edu
        • Investigador principal:
          • Bharat Panuganti, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Medicamento: 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.
Outros nomes:
  • ICG
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Tumor-to-background ratio (TBR)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Washington University School of Medicine

Investigadores

  • Investigador principal: Bharat Panuganti, MD, FACS, Washington University School of Medicine

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

31 de outubro de 2026

Conclusão Primária (Estimado)

30 de abril de 2028

Conclusão do estudo (Estimado)

30 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

13 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de setembro de 2026

Primeira postagem (Real)

17 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 202608227

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

produto fabricado e exportado dos EUA

Não

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