Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Detect/localize thyroid nodules and lymph nodes in vivo by using tri-modal imaging
研究概览
简要总结
Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using ultrasound imaging and surgery is the most common treatment. However, most nodules are benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound imaging is very sensitive for localizing nodules, but does not differentiate between cancerous and benign ones. To address this limitation of US imaging, investigators have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs complimentary imaging modalities (ultrasound (US), photoacoustic (PA)) that could potentially help diagnose nodules without the need for biopsy and unnecessary surgery.
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 patients with thyroid nodules (cancerous, benign or undetermined)
- •18 years of age or older
- •Have been consented to their standard-of-care surgery for resection of the thyroid (partial or complete) and lymph nodes (if applicable)
- •Have had pre-surgical US imaging of the thyroid and lymph nodes
排除标准
- •Inability to provide informed consent
- •Pre-operative therapy for current thyroid cancer (including chemotherapy, endocrine therapy and radiotherapy)
- •History of photosensitivity or skin disease (exposure to laser light is involved in PA imaging)
研究组 & 干预措施
Tri-modal imaging
Ultrasound and photoacoustic imaging of thyroid and adjacent lymph nodes. Imaging time: Approximately 30 minutes
干预措施: Tri-modal imaging (Device)
结局指标
主要结局
Detect/localize thyroid nodules and lymph nodes in vivo by using tri-modal imaging
时间窗: up to 5 months
次要结局
未报告次要终点