Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Estimates of sensitivity and specificity using ICG.
研究概览
简要总结
This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult subjects at least 18 years of age.
- •Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.
- •Good operative candidate as determined by the treating physician and/or multidisciplinary team.
- •Subject capable of giving informed consent and participating in the process of consent.
- •A WOCBP must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).
排除标准
- •Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
- •A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:
- •they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or
- •they have had a hysterectomy.
- •Known allergy to iodides or shellfish.
- •Inadequate organ function at time of screening as defined below:
- •Total bilirubin >2 x Institutional Upper Limit of Normal (IULN). Participants with a history of Gilbert's disease must have total bilirubin <3mg/dL.
- •AST (SGOT) and ALT (SPGT) >3 x IULN.
- •Currently incarcerated individuals
研究组 & 干预措施
Single arm trial
干预措施: Indocyanine Green (ICG) (Drug)
结局指标
主要结局
Estimates of sensitivity and specificity using ICG.
时间窗: From time of surgery until final pathology results are available (about 2 weeks)
Sensitivity (specificity) will be estimated as the proportion of pathologically positive (negative) samples that do (do not) fluoresce using ICG.
次要结局
- Frequency and proportion of samples for which visualization is altered using dimension.(From surgery until final pathology results are available (about 2 weeks))
- Estimates of sensitivity and specificity using white light visualization.(From surgery until final pathology results are available (about 2 weeks).)
研究者
Jason Newman
Professor-Faculty
Medical University of South Carolina