Assessment of Novel Label-free Optical Imaging Technology for the Evaluation of Skin Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- qOBM Clinical Assessment
研究概览
简要总结
This clinical trial studies how well an optical imaging scan called quantitative oblique back-illumination microscopy (qOBM) helps in diagnosing skin cancer in patients with skin lesions. qOBM is a non-invasive procedure that uses red light for illumination, and may work better than no imaging procedures in aiding doctors in diagnosing skin lesions.
详细描述
PRIMARY OBJECTIVE:
I. To perform a first-in-human study to assess the ability of a qOBM handheld device to reliably image skin pathology in-situ and in-vivo.
SECONDARY OBJECTIVES:
I. Characterize a wide variety of lesions including but limited to:
Ia. Malignant lesions: basal cell cancers, squamous cell cancers, Merkel cell cancer, melanoma, etc,; Ib. Non-malignant lesions: keloids, surgical scars, actinic keratosis, benign and dysplastic nevi, cysts, lipoma; Ic. Inflammatory conditions: psoriasis, eczema, alopecia, acne, wounds, etc); Id. Characterize pre and post treatment changes in the lesion as well as the surrounding normal tissue stroma (examples, but not limited to: changes to hair follicles, epidermis, dermis, subcutaneous tissue, erector pillae muscles, vessels, nerves, etc); Ie. Correlate optical findings with histological findings for lesions that would have been removed surgically and/or are biopsied (examples, but not limited to: removal of a skin cancer where optical imaging is used to characterize peripheral extent of the lesion as well as depth of penetration, a benign versus malignant lesion, pigmented versus [vs] non-pigmented lesion, etc).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male or Female
- •Candidate with skin lesions
- •Signed study-specific informed consent prior to study entry
- •≥ 18 years old
排除标准
- •Prior surgery or radiotherapy to the area to be treated
结局指标
主要结局
qOBM Clinical Assessment
时间窗: Up to 12 months
Assessing the application of quantitative oblique back-illumination microscopy (qOBM) to assess skin pathology. Analysis will be descriptive in nature (e.g., appearance of cells in the epidermis, dermis, and basal junction). Quantitative analysis will include extracting image features such as mean, standard deviation, and kurtosis of the phase values; entropy, fractal dimension, gray level co-occurrence matrix, and other mathematical image features. Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria (Skin) Grade 0. No change over baseline, Grade 1. Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating, Grade 2. Tender or bright erythema, patchy moist desquamation/moderate edema, Grade 3. Confluent, moist desquamation other than skin folds, pitting edema, Grade 4. Ulceration, hemorrhage, necrosis
次要结局
- Usability of the qOBM Device(Up to 12 months)
研究者
Mohammad K. Khan
Principal Investigator
Emory University