Phase 2: testing Indocyanine green for Head and Neck Squamous Cell Carcinoma
This 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.
Official registry: https://clinicaltrials.gov/study/NCT07825597 · Washington University School of Medicine · enrollment listed as 25
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Indocyanine green, or Near-infrared fluorescence imaging. The registry lists allocation as na. This 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.
They plan to enroll about 25 people at St Louis. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
Interventions: Indocyanine green, Near-infrared fluorescence imaging
Primary outcome (registry wording): Tumor-to-background ratio (TBR)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Bharat Panuganti, MD, FACS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Washington University School of Medicine — St Louis, Missouri (recruiting)
FAQ about this NCT record
Is NCT07825597 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07825597?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07825597?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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