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临床试验/NCT00588315
NCT00588315进行中(未招募)不适用

In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

Memorial Sloan Kettering Cancer Center4 个研究点 分布在 1 个国家目标入组 1,889 人开始时间: 1999年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,889
试验地点
4
主要终点
The study is a descriptive one. No formal statistical testing of correlations will be performed.

研究概览

简要总结

The purpose of this study is to investigate new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.

The High-resolution OCT (Apollo Medical Optics) device can provide both cross-sectional and en-face images with cellular information. Real-time color images through the same objective with OCT are also provided to show the OCT imaging location of lesion. The color image can be registered simultaneously on a larger dermoscopic image obtained by an external dermoscope. The imaging mode of cross-sectional, en-face and color image can be switched arbitrarily to align the lesion and obtain high-resolution images efficiently. The total imaging time is around 10 to 15 minutes depending on the number of images to be obtained.

To help identify more diagnostic features of optical imaging and better understand their histology correlation, we have developed a novel technique called "precision biopsy". Precision biopsy is an optical imaging guided, feature-targeted mini-biopsy. Once the feature of interest is identified and isolated by the optical imaging, a 2.0 mm punch biopsy is performed. Besides cosmetic benefit of minimal scarring, this tissue sparing biopsy captures the "feature of interest" for histology revelation.

Additionally, the histologic features of precision biopsy will be compared to images gathered by multi-modal optical imaging. The precision biopsy will also be compared to the traditional shave biopsy or shave excision, to determine whether the diagnostic information is comparable between the two methods.

For live remote control (LRC) imaging consultation, MSK dermatologist will based on his clinical examination. An imaging technician will perform the clinical and dermoscopic imaging, while the expert reader will perform confocal imaging remotely via a HIPPA compliant Webex platform.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than or equal to 10 years of age.
  • Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
  • Healthy volunteer subjects older than or equal to 10 years old.
  • Ability to give informed consent.

排除标准

  • Patients who are allergic to fluorescein sodium.

研究组 & 干预措施

skin lesions

The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology

normal skin

The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology

结局指标

主要结局

The study is a descriptive one. No formal statistical testing of correlations will be performed.

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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