Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT07825597

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine green

Near-infrared fluorescence imaging

Study Details

Brief summary:

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT07825597

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Tumor-to-background ratio (TBR) [ Time Frame: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day) ]

Central Contacts and Locations

Central contacts

Bharat Panuganti, MD, FACS

314-362-7522bharatp@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Bharat Panuganti, MD, FACS

314-362-7522bharatp@wustl.edu

Principal Investigator:

Bharat Panuganti, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Indocyanine green
  • ICG
  • First-window imaging
  • Near-infrared fluorescence imaging
  • Tumor-to-background ratio
  • Intraoperative imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.