Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

Not Applicable

Terminated

• Conditions: Carcinoma, Basal Cell
• Interventions: Other: OCT Mapped

• Registration Number: NCT03420846
• Lead Sponsor: Michelson Diagnostics Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Study Start: 2018-07-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

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

Exclusion Criteria

• Patients with BCCs larger than 6 cm2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCT Mapped arm	OCT Mapped	OCT is used to map the tumour margins as the first stage MMS estimate

Primary Outcome Measures

Name	Time	Method
Average number of Mohs stages	1 day	Is the average number of Mohs stages \< 1.4 with a 95% confidence level. (P \< 0.025)

Secondary Outcome Measures

Name	Time	Method
Size of the surgical defect	1 day	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
Average time taken to perform OCT margin mapping	1 day	Show that the average time taken to perform OCT margin mapping is \< 5 minutes for lesions of area \< 2 cm2

Trial Locations

Locations (1)

SkinCare Network; 🇬🇧 London, United Kingdom