Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Sensitivity of Near Infrared Fluorescence Imaging
研究概览
简要总结
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers
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
- •Male or female 18 years of age or older
- •ECOG performance status 0-2
- •Histological confirmation of squamous cell carcinoma
- •Locating the primary tumour in the oral cavity or oropharynx
- •Disease operable for complete resection
- •Serum or urinary pregnancy test (as per centre practices) negative within 14 days prior to systemic indocyanin green injection (pre-operative visit), for women of childbearing age
- •Patient information and signed free and informed consent
- •Patient affiliated with a social security scheme or beneficiary of a similar scheme.
- •The patient must understand, sign and date the consent form prior to any protocol-specific procedures. The patient must be able and willing to comply with the study visits and procedures described in the protocol
排除标准
- •Severe medical co-morbidities or contraindications to surgery
- •Primary tumour not operable
- •History of head and neck cancer in the past 5 years
- •History of radiation for head and neck cancer
- •Metastatic cancer
- •Tumours with necrosis ranges in pre-operative imaging
- •History of invasive cancer unless there has been no recurrence for more than 5 years with an exception for non-melanoma skin cancers.
- •Pregnant or nursing woman
- •Allergy or hypersensitivity to the product being administered (its active substance or other ingredients), iodized products or crustaceans.
- •Hyperthyroidism, thyroid adenoma, unifocal, multifocal or multinodular goiter of autoimmune origin.
- •Documented coronary artery disease
- •Advanced renal failure (creatinine > 1.5mg/dL).
- •Within 2 weeks prior to inclusion, concomitant medication that reduces or increases extinction of GI (i.e. anticonvulsants, haloperidol and Heparin).
- •Patient under guardianship or curatorship or deprived of liberty by judicial or administrative decision or patient unable to give consent.
- •Patients unable to undergo medical follow-up of the trial
研究组 & 干预措施
Patients with head and neck cancer
干预措施: indocyanine green (Drug)
结局指标
主要结局
Sensitivity of Near Infrared Fluorescence Imaging
时间窗: at surgery
Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection. For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N.
次要结局
未报告次要终点