Reflectance Confocal Microscopy to Diagnose BCC

Skin Care Network

Status: Completed

Conditions: Basal Cell Carcinoma

Treatments: Diagnostic Test: In-vivo imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT03509415

HS-MAV-003

Details and patient eligibility

About

It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.

Full description

Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC.

Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%.

The secondary hypothesis is that the intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).

Patients will be recruited from the outpatient clinic of Skin Care Network London.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
3. Patient willing and able to give informed consent

Exclusion criteria

1. Recurrent or other higher-risk BCC
2. Patient with basal cell naevus syndrome
3. Patient treated with hedgehog inhibitor medication (vismodegib)
4. Patient not suitable for diagnostic biopsy
5. Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
6. Patient with co-morbidities such as other skin disease

Trial design