NCT07182240招募中不适用
Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of cases with fully evaluable images
研究概览
简要总结
To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).
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
- •Age ≥ 18 years
- •Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.
- •Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.
- •The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.
排除标准
- •Known or reported allergy to mineral oil, the optical agent used during imaging.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •. Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
- •Unwilling or unable to follow protocol requirements
研究组 & 干预措施
Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT)
Other
LC-OCT imaging
干预措施: LC-OCT Imaging (Device)
结局指标
主要结局
Number of cases with fully evaluable images
时间窗: 1.5 years
cases were the image evaluator can assess the margins based on image quality
次要结局
- Patient interest in study(1.5 years)
- Patients overall experience(one office visit - immediately after imaging procedure)
- Determine LC-OCT imaging's impact on surgical workflow(To be filled out immediately after finishing Mohs procedure)
- Accuracy of LC-OCT findings(1.5 years)
- Accuracy of LC-OCT in detectng location of tumor(1.5 years)
研究者
研究点 (1)
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