Reflectance Confocal Microscopy to Diagnose BCC

Basal Cell Carcinoma Clinical Trial

Official title:

Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509415
• Other study ID #: HS-MAV-003
• Status: Completed
• Start date: March 15, 2017
• Est. completion date: December 28, 2019

Study information

• Verified date: April 2024
• Source: Skin Care Network Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Diagnostic Test:
• In-vivo imaging
Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

Locations

Country	Name	City	State
United Kingdom	Skin Care Network Barnet Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Skin Care Network Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity	Specificity & Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology	During exam (biopsy results typically available within one week).
Secondary	intra- & inter-observer agreement for interpreting the RCM images	A measure of how consistently readers can diagnose from confocal images.	6 months