Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Tumor-to-background ratio (TBR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Near-infrared fluorescence imaging (Procedure)
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.
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Tumor-to-background ratio (TBR)
时间窗: 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.
次要结局
- Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection(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(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(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(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(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(During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day))