NCT04368247已完成不适用
Skin Fluorescent Imaging (SFI) System in Patients With Nevi
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Establish the performance of SFI
研究概览
简要总结
The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.
详细描述
The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •In order to be eligible to participate in this study a subject must meet all of the following criteria:
- •Provide a signed and dated informed consent form
- •Age ≥ 18 years old
- •Subjects must present with suspicious atypical nevi scheduled for a biopsy*
- •Nevi with at least 1 cm of skin surrounding the mole
- •Nevi must be accessible to the SFI imaging device
- •Excisional or a tangential excision with a dept of 1 to 2 mm biopsy will be performed for the mole tested within 21 days of testing.
- •Nevi with clinically atypical features
- •Only 1 mole per eligible subject will be SFI tested in this study. *NOTE: a subset of patients (~10%) with benign nevi (by clinical observation) who wish to have nevi removed for cosmetic reasons will be enrolled as negative controls.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Subjects who are younger than 18 years old
- •Lesions that are consistent with
- •Features of Keratosis and keratin plugs
- •Basal Cell Carcinoma
- •Squamous Cell Carcinoma
- •Challenging anatomical location (e.g., body cervices)
- •Subjects with nevi that fit the inclusion criteria but are:
- •Less than 1 cm from the eyes
- •On the palms of the hands or soles of the feet
- •Associated with scar tissue
- •Mucosal lesions
- •Ulcerated lesions / breached skin
- •Lesions with some clinical certainty of being melanomas (large, dark, etc.)
- •Any nevi with ink marking including tattoos, on or adjacent to the nevi
- •Lesions treated with local anesthesia such as lidocaine prior to enrollment
- •Lesions larger than 20 mm or too large to allow imaging
- •Subject is known to be pregnant
- •Subject who is mentally or physically unable to comply with all aspects of the study
- •Subject who is undergoing systemic cancer treatment within 6 months of SFI testing
- •Subject with hypersensitivity to any of the SFI reagents
- •Subjects with known sensitivity to fluorescent dyes
- •Any subject who has previously participated (testing to biopsy) in SFI 003
结局指标
主要结局
Establish the performance of SFI
时间窗: 1year
Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.
次要结局
- To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.(1 year)
- To compare SFI to clinical diagnosis.(1 year)
研究者
研究点 (4)
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