Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
研究概览
简要总结
This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.
SECONDARY OBJECTIVES:
I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.
- •Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
- •Planned standard of care surgery with curative intent for squamous cell carcinoma.
- •Have life expectancy of more than 12 weeks.
- •Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level
- •Hemoglobin >= 9 gm/dL.
- •White blood cell count > 3000/mm^
- •Platelet count >= 100,000/mm^
- •Serum creatinine =< 1.5 mg/dL.
- •Liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin) =< 1.5 times the upper reference range.
- •Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.
- •Agree to not have radioactive iodine uptake studies done within 1 week of indocyanine green.
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- •Allergy to iodine or iodinated materials.
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- •Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
研究组 & 干预措施
Treatment (near-infrared image guided surgical resection)
Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
干预措施: Image-Guided Surgery (Procedure)
Treatment (near-infrared image guided surgical resection)
Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
干预措施: Indocyanine Green Drug (Drug)
结局指标
主要结局
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
时间窗: Up to 30 days
Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
次要结局
- Successful tumor fluorescence imaging data gathered for all patients included in the study(Up to 30 days)