NCT03420846

Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Michelson Diagnostics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Carcinoma, Basal Cell

Interventions

Type	Name	Description
OTHER	OCT Mapped	Presurgical mapping of Basal Cell Carcinoma margins

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2018-02-05
• Last updated: 2020-01-28

Locations

1 site across 1 country: United Kingdom