Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carcinoma, Basal Cell

Intervention / Treatment
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* Other: OCT Mapped


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy-proven BCCs who have been referred for MMS Exclusion Criteria: Patients with BCCs larger than 6 cm2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to two arms. Participants in the first arm receive Mohs surgery using OCT mapping to delineate tumor margins. Participants in the Control Arm receive Mohs surgery using clinical estimation of tumor margins (ie. standard care) The average number of Mohs surgery cycles will be compared for the two arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT Mapped arm<br>OCT is used to map the tumour margins as the first stage MMS estimate | Other: OCT Mapped<br>* Presurgical mapping of Basal Cell Carcinoma margins<br>|
| No Intervention: Control arm<br>Standard MMS is performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of Mohs stages | Is the average number of Mohs stages < 1.4 with a 95% confidence level. (P < 0.025) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the surgical defect | Validate that the reduction in MMS stages by use of OCT mapping does not result in an increase in the size of the surgical defect | 1 day | 
| Average time taken to perform OCT margin mapping | Show that the average time taken to perform OCT margin mapping is < 5 minutes for lesions of area < 2 cm2 | 1 day |