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临床试验/NCT05138328
NCT05138328已完成不适用

Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Clearance by imaging

研究概览

简要总结

This pilot study will examine the treatment of basal cell carcinoma (BCC) with laser technology under the guidance of imaging modalities to assist with surgical excision, including optical coherence tomography imaging (OCT) and reflectance confocal microscopy (RCM). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a nonablative laser already shown to effectively treat BCC. The addition of OCT and RCM has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. OCT is being used to enhance the effectiveness of Mohs Micrographic Surgery of these cancers by elucidating more definitive tumor margins. RCM has been shown to detect changes in the composition of cells consistent with BCC.

We propose to use these imaging devices to guide the laser treatment to achieve optimal efficacy with minimized side-effects. Primary outcome measured include complete clearance of the BCC lesion, which will be determined through clinical examination, dermoscopy, imaging (OCT and/or RCM), and saucerization biopsy. Secondary outcome variables include the significance of lesion depth (by OCT and/or RCM), lateral extent (by OCT and/or RCM), BCC type, and anatomical region on rate of clearance and recurrence.

研究设计

研究类型
Interventional
分配方式
Na
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 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • At least one (1) biopsy-proven superficial or nodular BCC, less than or equal to 2.0 cm in largest dimension
  • Willing to have photographs taken of the treatment area
  • Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative

排除标准

  • Pregnancy
  • Patients with a BCC lesion that requires excision. This would include relatively large lesions (greater than or equal to >2.0 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.
  • Subjects unable to follow-up for the full 12 months
  • Subjects not willing to have biopsy taken from the treatment area
  • Subjects with herpes simplex virus infection in treatment areas.

结局指标

主要结局

Clearance by imaging

时间窗: 3-15 months after treatment

Clearance of BCC as indicated by imaging of optical coherence tomography (OCT)

Clearance by biopsy

时间窗: 3-15 months after treatment

Clearance of BCC as indicated by biopsy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David M. Ozog

Chair, Department of Dermatology

Henry Ford Health System

研究点 (2)

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