Clinical trial · Observational
Reflectance Confocal Microscopy to Diagnose BCC
Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
NCT03509415CI-TRIAL-00076087completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In-vivo imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and Specificity
- timeFrame
- During exam (biopsy results typically available within one week).
- description
- Specificity \& Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology
Secondary outcomes (1)
- measure
- intra- & inter-observer agreement for interpreting the RCM images
- timeFrame
- 6 months
- description
- A measure of how consistently readers can diagnose from confocal images.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDStevens HP, Pampena R, Farnetani F, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy in diagnosing basal cell carcinoma in the UK: a prospective observational single-centre trial. Br J Dermatol. 2025 Jan 24;192(2):206-214. doi: 10.1093/bjd/ljae356. PMID 39259284