Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
2022年3月2日 更新者:Jonsson Comprehensive Cancer Center
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
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.
研究概览
详细说明
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:
Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.
After completion of study treatment, patients are followed up for 14-30 days.
研究类型
介入性
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90095
- UCLA / Jonsson Comprehensive Cancer Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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 1.
- Hemoglobin >= 9 gm/dL.
- White blood cell count > 3000/mm^3.
- Platelet count >= 100,000/mm^3.
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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Undergo near-infrared image guided surgical resection
Given IV
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
大体时间:Up to 30 days
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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.
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Up to 30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Successful tumor fluorescence imaging data gathered for all patients included in the study
大体时间:Up to 30 days
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The effect of indocyanine green will be assessed by changes in tumor-to-background ratio (TBR).
Tumor to background (TBR) data will be generated from still images collected throughout the procedure as previously described (Heath, Deep et al.).
The presence of fluorescence in normal surrounding tissue will be correlated with fluorescence within the tumor mass.
The linear relationship between fluorescence and tumor size will be computed as Spearman?s
correlation coefficient.
Continuous variable means (e.g., fluorescence intensity) will be compared to histological quantification of tumor as measured by the greatest dimension identified on the histopathological assessment.
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Up to 30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Abie Mendelsohn、UCLA / Jonsson Comprehensive Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年12月12日
初级完成 (预期的)
2021年6月8日
研究完成 (预期的)
2021年6月8日
研究注册日期
首次提交
2018年11月15日
首先提交符合 QC 标准的
2018年11月15日
首次发布 (实际的)
2018年11月19日
研究记录更新
最后更新发布 (实际的)
2022年3月17日
上次提交的符合 QC 标准的更新
2022年3月2日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Image-Guided Surgery的临床试验
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The Second Hospital of Shandong University完全的