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

13 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

25

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Bharat Panuganti, MD, FACS
  • Numer telefonu: 314-362-7522
  • E-mail: bharatp@wustl.edu

Lokalizacje studiów

  • Stany Zjednoczone
    • Missouri
      • St Louis, Missouri, Stany Zjednoczone, 63110
        • Washington University School of Medicine
        • Kontakt:
        • Główny śledczy:
          • Bharat Panuganti, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Lek: 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.
Inne nazwy:
  • ICG
Procedura: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Tumor-to-background ratio (TBR)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Washington University School of Medicine

Śledczy

  • Główny śledczy: Bharat Panuganti, MD, FACS, Washington University School of Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

31 października 2026

Zakończenie podstawowe (Szacowany)

30 kwietnia 2028

Ukończenie studiów (Szacowany)

30 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

13 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 września 2026

Pierwszy wysłany (Rzeczywisty)

17 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 202608227

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

produkt wyprodukowany i wyeksportowany z USA

Nie

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