Reflectance Confocal Microscopy to Diagnose MM & LM

NCT03508297 | Completed

• 1 other identifier: HS-MAV-002
• Study Type: observational
• Target: 597
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma (Skin); Lentigo Maligna

Keywords

Confocal; RCM; Imaging; Skin cancer

Outcome Measures

Primary Outcomes (1)

• Number Needed to Excise

  The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion

  During exam (biopsy results typically available within one week).

Secondary Outcomes (1)

• intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater

  6 months

Interventions

In-vivo imaging DIAGNOSTIC_TEST

Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for LM or MM.

You may qualify if:

• Age 18 years or older
• Patient with a pigmented lesion recommended for excision because of suspicion of MM or LM.
• Patient willing and able to give informed consent

You may not qualify if:

• Recurrent MM or LM
• Patient on immunosuppresants
• Patient with significant co-morbidity or skin disease
• Patient not suitable for diagnostic biopsy
• Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator

Sponsors & Collaborators

• Skin Care Network Ltd.: lead

Study Sites (1)

Skin Care Network Barnet Ltd

London, EN5 4QS, United Kingdom

Location

Related Publications (1)

• Stevens 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 DERIVED

MeSH Terms

Conditions

Melanoma; Hutchinson's Melanotic Freckle; Skin Neoplasms

Interventions

Intravital Microscopy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Howard Stevens, MA PhD

  Skin Care Network Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: March 14, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)