Clinical Implementation of a Novel Ultrasound Technology for the Evaluation of Skin Lesions and Sentinel Lymph Node
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Pre and post treatment changes in lesions
研究概览
简要总结
This trial studies the use of a novel non-invasive ultrasound technique in diagnosing patents with skin lesions. Diagnostic procedures, such as ultrasound, may be a less invasive way to check skin lesions for skin cancer and other skin disorders.
详细描述
PRIMARY OBJECTIVES:
I. Characterize a wide variety of lesions including but limited to:
I a. Malignant lesions: basal cell cancers, squamous cell cancers, Merkel cell cancer, melanoma, etc.
I b. Non-malignant lesions: keloids, surgical scars, actinic keratosis, benign and dysplastic nevi, cysts, lipoma.
I c. Inflammatory conditions: psoriasis, eczema, alopecia, acne, wounds, etc). I d. Determine if ultrasound can be used to more effectively/accurately administer treatment (injections, surgical procedures, 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
- Single (Investigator)
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
- •Candidate with skin lesions.
- •Signed study-specific informed consent prior to study entry.
排除标准
- •Prior surgery or radiotherapy to the area to be treated.
研究组 & 干预措施
Cohort I (ultrasound)
Patients with skin lesions undergo at least 1 ultrasound during the consultation. Patients may undergo at most 2 additional scans after the standard of care approach for non-malignant lesions at the discretion of the radiation oncologist and/or dermatologist.
干预措施: Ultrasound (Procedure)
Cohort II (ultrasound)
Skin cancer patients who undergo surgery or radiation undergo 2-5 ultrasounds over a 1 year period (a baseline ultrasound scan may be performed prior to treatment, followed by 1 scan during and/or after radiation, and additional ultrasounds may be conducted [at the discretion of the treating physician] upon completion of radiation and/or surgery, at approximately 1, 6, and 12 month follow-up examinations).
干预措施: Ultrasound (Procedure)
Cohort III (ultrasound)
Participants with inflammatory skin disorders (psoriasis, eczema, alopecia, acne) undergo ultrasound at baseline and follow-up visits.
干预措施: Ultrasound (Procedure)
结局指标
主要结局
Pre and post treatment changes in lesions
时间窗: 12 months from study start
Ultrasound findings will be reviewed for changes in lesions.
次要结局
未报告次要终点
研究者
Mohammad K. Khan
Principal Investigator
Emory University