NCT00937690已完成不适用
Pilot Study of Infrared Imaging of Cutaneous Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter
研究概览
简要总结
Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. Participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients or volunteers with or without a history of melanoma.
- •One or more palpable skin or subcutaneous lesions for which at least one of the following is true:
- •A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1).
- •A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2).
- •A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B).
- •All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry.
排除标准
- •Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions.
- •Very fragile skin that may be susceptible to injury from adhesive markers.
- •Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
结局指标
主要结局
preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter
时间窗: one day - 24 hours
次要结局
- to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis(one day-24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Skin IaM: An Exploratory Clinical Trial to Evaluate Changes in Skin Appearance, Colour, and/or Texture Following the Induction of a Local Inflammatory Skin ResponseSkin InflammationNCT03192280LEO Pharma12
已完成
不适用
Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.Skin LesionsNCT02009085Orlucent, Inc126
撤回
不适用
Optical Frequency Domain Imaging (OFDI) in DermatologyPort Wine StainNCT01438047Massachusetts General Hospital
已完成
不适用
Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck CancerMalignant MelanomaHead and Neck CancerNCT02331134University of Colorado, Denver9
进行中（未招募）
不适用
Skin Imaging With Technologies in DevelopmentPigmented Skin Lesion of Uncertain NatureNCT00764920University of California, Irvine750