Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

NCT ID: NCT03420846

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-09-01

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.

Conditions

Carcinoma, Basal Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OCT Mapped arm

OCT is used to map the tumour margins as the first stage MMS estimate

Group Type: EXPERIMENTAL

OCT Mapped

Intervention Type: OTHER

Presurgical mapping of Basal Cell Carcinoma margins

Control arm

Standard MMS is performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OCT Mapped

Presurgical mapping of Basal Cell Carcinoma margins

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients with BCCs larger than 6 cm2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Skin Care Network Ltd.

INDUSTRY

Sponsor Role: collaborator

Michelson Diagnostics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Stevens

Role: PRINCIPAL_INVESTIGATOR

Skin Care Network Ltd.

Locations

SkinCare Network

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

1202

Identifier Type: -

Identifier Source: org_study_id