Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.
研究概览
简要总结
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
详细描述
Work package I:
In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.
Work package II:
In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:
- sensitivity, specificity, positive and negative predictive values of FLI;
- colocalization with immunohistochemistry;
- change in surgical management; incremental operation time;
- FLI of excised cervical lymph nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- •≥ 18 years of age;
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- •Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
排除标准
- •Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- •History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- •Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- •Patients with renal insufficiency (eGFR<60);
- •Patients with a previous kidney transplantation in the medical history;
- •Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
- •Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
研究组 & 干预措施
WP-I dose B
n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.
干预措施: cRGD-ZW800-1. (Drug)
WP-II selected dose
n=14: expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. Injection of 0.05 ór (to be determined) mg/kg cRGD-ZW800-1, within 48 hours before imaging/surgery.
干预措施: cRGD-ZW800-1. (Drug)
WP-I dose A
n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery
干预措施: cRGD-ZW800-1. (Drug)
结局指标
主要结局
WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.
时间窗: through histopathology, up to max 4 weeks post-op
WP-I: (Highest) mean tumor-to-background ratio (TBR)
时间窗: up to 48 ours post-dose
Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR.
次要结局
- WP-II: Sensitivity, specificity, positive and negative predictive values(through histopathology, up to max 4 weeks post-op)
- WP-II: Co-localization of FLI with immunohistochemistry on pathology slides(through histopathology, up to max 4 weeks post-op)
- WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections(through histopathology, up to max 4 weeks post-op)
- WP-II: FLI of lymph node metastases after neck dissection(through histopathology, up to max 4 weeks post-op)
- WP-II: Operation time(through histopathology, up to max 4 weeks post-op)
研究者
Stijn Keereweer
Principal Investigator
Erasmus Medical Center