+1 Recommend
1 collections

      To submit your manuscript, please click here

      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Evaluating the Diagnostic Accuracy of Reflectance Confocal Microscopy to Diagnose Skin Cancer: Protocol for a Prospective, Multicenter Study

      , MSc 1 , , , MD, PhD 1 , , MSc 1 , , PhD, FIPEM, FInstP 1 , , PhD, FIPEM 2 , , MBChB, FRCP 2 , , MBBS, PhD 2
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      melanoma, lentigo maligna, biopsy, dermoscopy, reflectance confocal microscopy

      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.



          In the United Kingdom, 350,000 patients per year are referred to hospital clinics with suspicious moles, and approximately half undergo a biopsy to identify the 5%-10% who require further treatment. If cancer cannot be ruled out clinically and on the basis of biopsy results, the lesion is surgically removed. One type of precancerous mole, called lentigo maligna, is particularly challenging to delineate and treat. Reflectance confocal microscopy (VivaScope, Caliber Imaging & Diagnostics) is an imaging technique that can supplement dermoscopy in identifying whether a clinically suspicious mole is malignant and can better assess lentigo maligna margins for excision. It allows clinicians to visualize the skin lesion to a depth of 200 microns with subcellular resolution, described as quasi-histological, and therefore better guide more accurate diagnoses.


          The aim of this paper is to describe a prospective, single blinded, multicenter study to examine patients with clinically suspicious moles or lentigo maligna to determine whether confocal microscopy can both reduce the number of unnecessary biopsies of moles and more accurately guide the surgical excision margins of lentigo maligna.


          This study will prospectively recruit adults into the following two cohorts: diagnostic accuracy and margin delineation. The diagnostic accuracy cohort will assess people with clinically suspicious lesions suspected of being diagnosed with melanoma and having an equivocal finding on dermoscopy or persistent clinical suspicion despite normal dermoscopy. Diagnostic accuracy will include the sensitivity and specificity of VivaScope in comparison with the histological diagnosis as the gold standard for patients. The margin delineation cohort will assess the ability of VivaScope to accurately delineate the margins of lentigo maligna compared with that of dermoscopy alone using margins taken during Mohs micrographic surgery as the gold standard. The primary study outcomes will be the diagnostic accuracy of VivaScope for the first cohort of patients and margin agreement between VivaScope and the final pathology report for the second cohort of patients.


          Funding for this proposed research is being secured.


          The outcomes of the proposed study will indicate how many biopsies of nonmelanoma lesions, which are potentially unnecessary, could be prevented. This would reduce patient anxiety and cost to the National Health Service (NHS) in the United Kingdom. Improved margin delineation of lentigo maligna could also improve the surgical clearance rates and decrease overall cost. The results would demonstrate whether the adoption of VivaScope would potentially benefit patients and the NHS.

          Registered Report Identifier


          Related collections

          Most cited references10

          • Record: found
          • Abstract: found
          • Article: not found

          Impact of in vivo reflectance confocal microscopy on the number needed to treat melanoma in doubtful lesions.

          The number needed to treat (NNT) ratio is an effective method for measuring accuracy in melanoma detection. Dermoscopy reduces the number of false positives and subsequently unnecessary excisions. In vivo reflectance confocal microscopy (RCM) is a noninvasive technique that allows examination of the skin with cellular resolution.
            • Record: found
            • Abstract: found
            • Article: not found

            Sensitivity and specificity of confocal laser-scanning microscopy for in vivo diagnosis of malignant skin tumors.

            Melanoma and nonmelanoma skin cancer are the most frequent malignant tumors by far among whites. Currently, early diagnosis is the most efficient method for preventing a fatal outcome. In vivo confocal laser-scanning microscopy (CLSM) is a recently developed potential diagnostic tool. One hundred seventeen melanocytic skin lesions and 45 nonmelanocytic skin lesions (90 benign nevi, 27 malignant melanomas, 15 basal cell carcinomas, and 30 seborrheic keratoses) were sampled consecutively and were examined using proprietary CLSM equipment. Stored images were rated by 4 independent observers. Differentiation between melanoma and all other lesions based solely on CLSM examination was achieved with a positive predictive value of 94.22%. Malignant lesions (melanoma and basal cell carcinoma) as a group were diagnosed with a positive predictive value of 96.34%. Assessment of distinct CLSM features showed a strong interobserver correlation (kappa >0.80 for 11 of 13 criteria). Classification and regression tree analysis yielded a 3-step algorithm based on only 3 criteria, facilitating a correct classification in 96.30% of melanomas, 98.89% of benign nevi, and 100% of basal cell carcinomas and seborrheic keratoses. In vivo CLSM examination appeared to be a promising method for the noninvasive assessment of melanoma and nonmelanoma skin tumors. Copyright 2006 American Cancer Society.
              • Record: found
              • Abstract: found
              • Article: not found

              In vivo reflectance confocal microscopy enhances secondary evaluation of melanocytic lesions.

              We recently described an in vivo reflectance confocal microscopy (RCM) method and our aim was to evaluate a possible additive value of this type of analysis in the management of melanocytic lesions. In two referral centers (Sydney and Modena), lesions (203 nevi and 123 melanomas (MMs) with a median Breslow thickness of 0.54 mm) were excised on the basis of clinical suspicion (history, dermoscopy examination, and/or digital monitoring). The RCM method was also trialed on a non-biopsied population of 100 lesions, which were clinically and dermoscopically diagnosed as benign nevi. All RCM and dermoscopy diagnoses were performed blinded to the histopathological diagnosis. Firstly, in the study population, a high interobserver agreement (on a subset of 90 lesions) was seen with the RCM method, which had superior specificity (68%, 95% confidence interval (95% CI): 61.1-74.3) for the diagnosis of MM compared with dermoscopy (32%, 95% CI: 25.9-38.7), while showing no difference in sensitivity (91%, 95% CI: 84.6-95.5, RCM; 88%, 95% CI: 80.7-92.6 dermoscopy). The two techniques had a weak correlation, resulting in only 2.4% of MMs being misclassified by both techniques. Diagnosis of light-colored lesions is improved by RCM (specificity 84%, 95% CI: 66.3-94.5) compared with dermoscopy (specificity 39%, 95% CI: 23.7-56.2). Secondly, the RCM method classified 100% of the non-biopsied control nevi population as benign.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                August 2018
                09 August 2018
                : 7
                : 8
                : e170
                [1] 1 King's Technology Evaluation Centre School of Biomedical Engineering & Imaging Sciences King's College London London United Kingdom
                [2] 2 Guy's and St Thomas' NHS Foundation Trust London United Kingdom
                Author notes
                Corresponding Author: Naomi D. Herz naomi.herz@ 123456gmail.com
                Author information
                ©Naomi D. Herz, Anastasia Chalkidou, Fiona Reid, Stephen F. Keevil, Andrew Coleman, Emma Craythorne, Rakesh Patalay. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.08.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                : 30 October 2017
                : 15 March 2018
                : 7 May 2018
                : 11 May 2018

                melanoma,lentigo maligna,biopsy,dermoscopy,reflectance confocal microscopy


                Comment on this article