Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This phase I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery.
详细描述
OUTLINE:
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
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 age >= 18 years (yr)
- •Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery
- •Able to provide written informed consent
- •If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential
- •Available for all study visits and able to comply with all study requirements
排除标准
- •Known or suspected sensitivity to indocyanine green
- •In the opinion of the treating physician, subject has received photosensitizing medication that could interfere or confound study results
- •Any current medications with the potential to generate fluorescence or photochemical reaction
- •Enrolled in any other ongoing study
- •Currently lactating or breastfeeding
- •Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide
- •Any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data
- •Creatinine clearance < 60 mL/min
- •Aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) > 1.5 x ULN
- •Bilirubin > 1.5 x ULN
研究组 & 干预措施
Diagnostic (tozuleristide, surgery, NIR imaging)
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
干预措施: Tozuleristide (Drug)
Diagnostic (tozuleristide, surgery, NIR imaging)
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
干预措施: Near Infrared Imaging (Procedure)
Diagnostic (tozuleristide, surgery, NIR imaging)
Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: 7-21 days after drug administration
Adverse events will be summarized as the number and percentage of patients with each type of adverse event, per Criteria for Adverse Events version 5.0.
Number of Adverse Events (AEs)
时间窗: 7-21 days after drug administration
Adverse events will be summarized as the number of each type of adverse event, per Criteria for Adverse Events version 5.0.
次要结局
- Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies(Up to 12 months)
- Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies(Up to 12 months)
- Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies(Up to 12 months)
- Achievement of negative margins in tozuleristide-guided oral cavity tumor excision(Up to 12 months)
- Number of subjects without tumor fluorescence after receiving tozuleristide(Up to 12 months)
- Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies(Up to 12 months)
- Number of Subjects Without Tumor Fluorescence After Receiving Tozuleristide(Measured at time of surgery 1 to 30 hours after receiving tozuleristide)
- Number of Participants for Which Negative Margins Were Achieved in Tozuleristide-guided Oral Cavity Tumor Excision(Surgery performed following tozuleristide injection 1-30 hours prior to surgery)
研究者
Emily Marchiano
Assistant Professor
University of Washington