NCT03032198终止不适用
"Early R&D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
研究概览
简要总结
Thyroid Feasibility Study
详细描述
This is an early R&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules
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
- •Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
- •Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
- •18 years of age or older at the time of consent;
- •Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
- •Have received recommendation for and are scheduled for an ultrasound guided FNAB, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule.
排除标准
- •Are prisoners;
- •Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule),
- •Previous or on-going radioactive iodine treatment.
- •Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
- •Is pregnant;
- •Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
- •Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
- •Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
- •Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;
- •Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and,
- •Patient has previously participated in this study.
结局指标
主要结局
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
时间窗: 12-24 months
The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.
次要结局
未报告次要终点
研究者
研究点 (4)
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