Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

Carcinoma, Basal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03420846
• Other study ID #: 1202
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2020
• Source: Michelson Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with BCCs larger than 6 cm2

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

Other:
• OCT Mapped
Presurgical mapping of Basal Cell Carcinoma margins

Locations

Country	Name	City	State
United Kingdom	SkinCare Network	London

Sponsors (2)

Lead Sponsor	Collaborator
Michelson Diagnostics Ltd.	Skin Care Network Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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