Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sensitivity of indocyanine green labeling in Irradiated Area
研究概览
简要总结
Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.
Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.
The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.
The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient over 18 years old
- •Head and Neck Squamous Cell Carcinoma confirmed by biopsy
- •Non metastatic disease
- •Resectable tumour
- •Locoregional recurrence or new localization in pre irradiated territory at a dose ≥ 50 Gy with or without chemotherapy
- •Haematological constants, liver function and kidney function adapted in the 15 days before inclusion:
- •Haemoglobin ≥ 9 g / dL
- •Polymorphonuclear neutrophils ≥ 1.5 x 10 9
- •Platelet ≥ 100 x 109 / L
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT and AST <3 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Serum creatinine <110 mmol / L or creatinine clearance> 55 ml / min (method of Cockcroft)
- •Absence of proteinuria
- •WHO 0 or 1
- •Signed informed consent form
- •Patient affiliated to the social security system.
排除标准
- •Patient considered as non eligible for a salvage surgery
- •Metastatic disease
- •Hypersensitivity to indocyanine green or allergy to seafood or reaction to iodinated contrast agents
- •Pregnant or breastfeeding women
研究组 & 干预措施
eligible patient for a salvage surgery
干预措施: indocyanine green (Drug)
结局指标
主要结局
Sensitivity of indocyanine green labeling in Irradiated Area
时间窗: 1 day
The indocyanine green labeling in irradiated areas will be compared to the histological result on the surgical specimen.
次要结局
- Sensitivity of indocyanine green labeling on surgical margins(1 day)