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临床试验/NCT03420846
NCT03420846终止不适用

Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping Using Optical Coherence Tomography

Michelson Diagnostics Ltd.2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
86
试验地点
2
主要终点
Average number of Mohs stages

研究概览

简要总结

This Interventional Randomised Controlled study is intended to establish that presurgical margin mapping of BCCs with OCT results in a reduction of the number of MMS surgery stages without adversely impacting clinical outcome, resulting in shorter patient stays and more efficient use of surgical and operating room resources.

详细描述

Basal Cell Carcinoma (BCC) is the most common malignancy in humans. Its incidence is continuously increasing. The head and neck areas are most commonly affected due to their increased lifetime exposure to sun compared to other body parts. BCC is often treated by surgical excision which has high cure rate compared to other treatment modalities, but leaves a visible scar which can affect the quality of life of the patient, depending on the location and size of the excision. Mohs Micrographic Surgery (MMS) was developed to minimize the size of the surgical excision whilst maintaining very high cure rate. The main drawback of MMS is that repeated surgery procedures are usually required to eliminate all of the tumour using specialist resources located at the clinic.

Optical Coherence Tomography (OCT) allows non-invasive in-vivo imaging of superficial skin lesions. It is in routine clinical use for diagnosis of BCCs, and the diagnostic sensitivity and specificity is well established in published multi-centre trials. A further potential application of OCT is the pre-surgical mapping of the lateral margins of BCC. If the margins of a BCC were accurately known prior to commencing an MMS treatment, the treatment could be performed much more quickly, resulting in shorter patient stays and more efficient use of surgical and operating room resources. Previously published research has already shown that OCT mapping of BCC margins is more accurate than clinical assessment; the objective of the present study is to demonstrate that pre-surgical mapping of BCC margins with OCT is also more efficient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Patients with biopsy-proven BCCs who have been referred for MMS

排除标准

  • Patients with BCCs larger than 6 cm2

结局指标

主要结局

Average number of Mohs stages

时间窗: 1 day

Is the average number of Mohs stages \< 1.4 with a 95% confidence level. (P \< 0.025)

次要结局

  • Size of the surgical defect(1 day)
  • Average time taken to perform OCT margin mapping(1 day)

研究者

发起方
Michelson Diagnostics Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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