Clinical trial · Observational
Reflectance Confocal Microscopy to Diagnose MM & LM
Reflectance Confocal Microscopy to Diagnose Malignant Melanoma and Lentigo Maligna
- 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)
A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lentigo Maligna | Lentigo Maligna | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In-vivo imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number Needed to Excise
- timeFrame
- During exam (biopsy results typically available within one week).
- description
- The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion
Secondary outcomes (1)
- measure
- intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater
- 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 with a pigmented lesion recommended for excision because of suspicion of MM or LM. 3. Patient willing and able to give informed consent Exclusion Criteria: 1. Recurrent MM or LM 2. Patient on immunosuppresants 3. Patient with significant co-morbidity or skin disease 4. Patient not suitable for diagnostic biopsy 5. Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
References
Publications (1)
- DERIVEDStevens HP, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy to diagnose malignant melanoma and lentigo maligna in the UK: a single-centre prospective observational trial. Br J Dermatol. 2024 Dec 23;192(1):27-35. doi: 10.1093/bjd/ljae354. PMID 39255055