Clinical trial NCT03420846: Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping
Official title: Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping Using Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Basal Cell
Lead sponsor: Michelson Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Skin Care Network Ltd.
First posted: 2018-02-05
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with BCCs larger than 6 cm2

Primary outcomes:
measure: Average number of Mohs stages
timeFrame: 1 day
Secondary outcomes:
measure: Size of the surgical defect
timeFrame: 1 day
measure: Average time taken to perform OCT margin mapping
timeFrame: 1 day
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: SkinCare Network
Study officials:
affiliation: Skin Care Network Ltd.
name: Howard Stevens
role: PRINCIPAL_INVESTIGATOR
References: