A Phase I Feasibility Study of Intra-operative Near Infra-red Fluorescent Imaging in Thyroid/Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Determine patterns of fluorescence from soft tissue structures in the neck
研究概览
简要总结
Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid surgery.
Aims: The aims of this phase of the study are to determine the feasibility of using near infrared fluorescent technology in the detection of parathyroid tissue and its differentiation from adjacent soft tissue during surgery on parathyroid glands.
Objectives of the phase I study:
- To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device (Fluoptics).
- To understand the patterns (onset, intensity and duration) of fluorescent staining of normal parathyroid glands, thyroid glands and other soft tissue structures encountered during parathyroidectomy.
Further research:
This will be followed by a phase II study during which fluorescent imaging will be used in conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum possible dose of MB for the identification of parathyroid glands. This will then be tested in the pilot phase of a randomized clinical trial.
详细描述
As above
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
- •all patients undergoing parathyroid surgery
排除标准
- •patients undergoing re-do procedures
- •patients unable to give adequate informed consent
- •patients with a history of intolerance or sensitivity to MB
- •patients with G6PD deficiency
- •patients on serotonin reuptake inhibitors and patients undergoing thoracic exploration
- •either alone or in combination with a neck exploration.
结局指标
主要结局
Determine patterns of fluorescence from soft tissue structures in the neck
时间窗: 1 Day
This is a proof of principle study aimed to demonstrate that the patterns of Methylene Blue emitted fluorescence from the parathyroid glands, thyroid glands and other soft tissue structures in the neck such as lymph glands are distinct and can be used to differentiate between them at surgery. The fluorescence from the various structures will be recorded as 'no', 'mild' and 'yes'.
次要结局
未报告次要终点