Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete histological clearance of BCC lesion
研究概览
简要总结
Optical coherence tomography guided laser treatment of basal cell carcinoma
详细描述
The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative
- •Ages 18 and older
- •Seeks and is scheduled for treatment of a BCC previously confirmed with biopsy
排除标准
- •Any of the following will exclude participation in the study:
- •Inability to understand and/or carry out instructions
- •Patients with a BCC lesion that requires excision. This would include relatively large lesions (>2.5 cm diameter), lesions that penetrate deep into the skin beyond the depth of the OCT image capture, high risk lesions as defined by the American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
- •Patients with periocular BCCs which might expose the patient to risk of damage to eyes from the laser.
- •BCCs on legs due to their tendency towards poor wound healing.
- •Pregnancy
- •Patients unable to follow-up for the full 12 months.
结局指标
主要结局
Complete histological clearance of BCC lesion
时间窗: 1 year
Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results.
次要结局
未报告次要终点
研究者
Christopher Zachary
Professor of the UCI Department of Dermatology
University of California, Irvine