Evaluating the Diagnostic Accuracy of Reflectance Confocal Microscopy to Diagnose Skin Cancer: A Research Protocol (Preprint) (original) (raw)
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Journal of the European Academy of Dermatology and Venereology, 2018
Background: Lentigo maligna may be challenging to clear surgically. Objective: To evaluate feasibility of using superficial skin cuts as RCM imaging anchors for attaining negative surgical margins in lentigo maligna. Methods: Included patients presented with lentigo maligna near cosmetically-sensitive facial structures. We evaluated, with handheld-RCM, microscopic clearance of melanoma beyond its dermoscopically-detected edges. Evaluated margins were annotated using shallow skin-cuts. If a margin was positive at 'first-step' RCM evaluation, we sequentially advanced the margin radially Accepted Article This article is protected by copyright. All rights reserved. outward at that segment by 2mm intervals until an RCM-negative margin was identified. Prior to final surgical excision, we placed sutures at the outmost skin-cuts to allow comparison of RCM and histopathological margin assessments. Primary outcome measure was histopathological verification that RCM-negative margins were clear of melanoma. Results: The study included 126 first-step margin evaluations in 23 patients, median age 70 years (range: 43-91). Seventeen patients (74%) had primary in situ melanoma and 6 (26%) invasive melanoma, mean thickness 0.3mm (range 0.2-0.4mm). Six cases (26%) showed complete negative RCM margins on 'first-step', 11 (48%) were negative at 'second-step', and 4 (17%) at 'third-step'. In two additional cases (9%), margins clearance could not be determined via RCM due to widespread dendritic cells proliferation. The RCM-negative margins in all 21 cases proved clear of melanoma on histopathology. Of the 15 cases that returned at one-year-follow-up, none showed any residual melanoma on dermoscopic and RCM examinations. Inter-observer reproducibility showed fair agreement between bedside RCM reader and blinded remote-site reader, with Spearman's rho of 0.48 and Cohen's kappa of 0.43; using bedside reader as reference, the remote reader's sensitivity was 92% and specificity 57% in positive margin detection. Conclusions: Margin mapping of lentigo maligna with handheld-RCM, using superficial skin cuts, appears feasible. This approach needs validation by larger studies.
Handheld reflectance confocal microscopy to aid in the management of complex facial lentigo maligna
Cutis, 2017
Diagnosis and management of lentigo maligna (LM) and LM melanoma (LMM) is challenging. Novel noninvasive imaging technologies such as reflectance confocal microscopy (RCM) have advanced the ability to better diagnose and monitor challenging lesions. In addition, the new handheld RCM (HRCM) together with the use of videomosaics has allowed an accurate evaluation of large lesions in concave/convex areas of the body (eg, the face). Herein, we review the impact of HRCM in the detection, treatment decision-making, and monitoring of 5 cases of complex facial LM/LMM. In the cases presented, HRCM enabled the detection of subclinical margins, presence of invasion, detection of persistence/recurrence, and monitoring of surgical and nonsurgical therapies. In this preliminary report, our results suggest that HRCM is a versatile ancillary tool in pretreatment decision-making, intraoperative surgical mapping, and posttreatment monitoring of complex facial LM/LMM.
International Journal of Dermatology, 2020
Background In recent years, there has been an ongoing interest in topical treatment for lentigo maligna (LM) as imiquimod 5% cream owing to the localization of this tumor and the advanced age of patients; however, the efficacy of imiquimod 5% cream is controversial, and the rate of local relapses is about 25-53%. Reflectance confocal microscopy (RCM) is a noninvasive diagnostic tool useful not only for diagnostic purpose but also for monitoring the response to the local treatment of LM. Our aim was to demonstrate the role of RCM in the follow-up of a topical treatment with imiquimod 5% cream in clinical practice. Methods We report three patients with histopathologically confirmed LM who were not candidates for surgery and were successfully treated with imiquimod 5% cream. In such patients, dermatoscopic images and reflectance confocal microscopy were useful to evaluate treatment response and to verify long-term clinical benefits during the follow-up visits. Results No relapses were observed in our patients 18 months after the end of treatment; although, continuous follow-up visits are needed in these patients. Conclusions In the case series presented herein, we highlight the importance of RCM as a noninvasive tool to monitor the efficacy of imiquimod to treat LM during and after treatment. Detailed confocal images of two of our patients allowed us to establish the persistence of atypical cells and to continue treatment, although clinical and dermatoscopic examinations showed "apparent complete remission" after the first cycle of therapy.
Clinical Indications for Use of Reflectance Confocal Microscopy for Skin Cancer Diagnosis
JAMA Dermatology, 2016
n recent decades, the dermatoscope has been thought to be an essential tool for skin cancer diagnosis, and it is currently referred as the "dermatologist's stethoscope." 1-3 However, in some cases the diagnosis of malignant abnormalities is still challenging in a subset of difficult-to-diagnose melanomas (MMs) and nonmelanoma skin cancers. To narrow this gray zone, reflectance confocal microscopy (RCM), a second-level in vivo imaging technique, has proven to be a useful tool in saving unnecessary excisions of benign lesions that can look dermoscopically suspicious for skin cancer while catching MMs that are dermoscopically inconspicious. 4-8 Reflectance confocal microscopy provides a horizontal visualization of the skin at a nearly histological resolution and is currently a validated instrument for noninvasive diagnosis of skin tumors, already counting over 600 indexed articles. 4-15 Up-to-date, retrospective analyses 4-8,11-15 have demonstrated the capability of RCM to improve the diagnostic accuracy in skin cancer detection when combined with dermoscopy, but, to our knowledge, only 2 studies 16,17 have evaluated prospectively the real impact of RCM in the routine clinical workflow. These 2 articles assessed the reduction in number of lesions needed to excise to diagnose an MM achievable through RCM: lesions considered for the analysis were defined under the umbrella of "clinically and/or dermoscopically equivocal." However, this term encompasses a wide group of clinical and dermoscopic situations and does not provide clinicians with the best indications for referring patients to a tertiary center equipped with confocal microscopy for confocal analysis. To define the best indications for the use of RCM in daily practice, we prospectively evaluated the clinical and IMPORTANCE Reflectance confocal microscopy (RCM) improves diagnostic accuracy in skin cancer detection when combined with dermoscopy; however, little evidence has been gathered regarding its real impact on routine clinical workflow, and, to our knowledge, no studies have defined the terms for its optimal application. OBJECTIVE To identify lesions on which RCM performs better in terms of diagnostic accuracy and consequently to outline the best indications for use of RCM. DESIGN, SETTING, AND PARTICIPANTS Prospectively acquired and evaluated RCM images from consecutive patients with at least 1 clinically and/or dermoscopically equivocal skin lesion referred to RCM imaging, from January 2012 to October 2014, carried out in a tertiary referral academic center. MAIN OUTCOMES AND MEASURES A total of 1279 equivocal skin lesions were sent for RCM imaging. Spearman correlation, univariate, and multivariate regression models were performed to find features significantly correlated with RCM outcome. RESULTS In a total of 1279 lesions in 1147 patients, RCM sensitivity and specificity were 95.3% and 83.9%, respectively. The number of lesions needed to excise to rule out a melanoma was 2.4. After univariate and multivariate regression analysis, head and neck resulted as the most appropriate body location for confocal examination; RCM showed a high diagnostic accuracy for lesions located on sun-damaged skin (adjusted odds ratio [aOR], 2.13; 95% CI, 1.37-3.30; P=.001) and typified by dermoscopic regression (aOR, 2.13; 95% CI, 1.31-3.47; P=.002) or basal-cell carcinoma specific criteria (aOR, 9.35; 95% CI, 1.28-68.58; P=.03). CONCLUSIONS AND RELEVANCE Lesions located on the head and neck, damaged by chronic sun-exposure, and dermoscopically typified by regression represent best indications for the use of RCM.
Effect of Reflectance Confocal Microscopy for Suspect Lesions on Diagnostic Accuracy in Melanoma
JAMA Dermatology
ImportancePrevious systematic reviews and meta-analyses have concluded that given data paucity, a comparison of reflectance confocal microscopy (RCM) with dermoscopy is complex. They recommend comparative prospective studies in a real-world setting of suspect lesions.ObjectiveTo test the hypothesis that RCM reduces unnecessary lesion excision by more than 30% and identifies all melanoma lesions thicker than 0.5 mm at baseline.Design, Setting, and ParticipantsThis randomized clinical trial included 3165 patients enrolled from 3 dermatology referral centers in Italy between January 2017 and December 2019, with a mean (SD) follow-up of 9.6 (6.9) months (range, 1.9-37.0 months). The consecutive sample of 3165 suspect lesions determined through dermoscopy were eligible for inclusion (10 patients refused). Diagnostic analysis included 3078 patients (48 lost, 39 refused excision). Data were analyzed between April and September 2021.InterventionsPatients were randomly assigned 1:1 to standa...
The role of confocal microscopy in the dermato-oncology practice
Journal of medicine and life
Reflectance-mode confocal microscopy (RCM) is a new in vivo skin imaging technique. We present our one-year experience in RCM examinations in skin tumors and the retrospective analysis of patients enrolled in the Dermatological Department of 'N. Paulescu' Institute using the Fotofinder Dermoscope IIŴ for the dermatoscopy analysis and VivaScope 1500Ŵ for in vivo RCM. We established the rank of RCM in the complex algorithm of skin cancer diagnose, showing that the presented experience can open new possibilities to implement this automated image analyzing system in the routine practice. Our analyzed cases clearly showed that confocal microscopy, therefore, optical biopsy, could guide the clinician towards an accurate diagnosis before surgical removal. Moreover, we emphasized that the development of this technique increases the potential of future teledermatologic applications.
JAMA dermatology, 2017
The management of lentigo maligna (LM) and LM melanoma (LMM) is challenging because of extensive subclinical spread and its occurrence on cosmetically sensitive areas. Reflectance confocal microscopy (RCM) improves diagnostic accuracy for LM and LMM and can be used to delineate their margins. To evaluate whether handheld RCM with radial video mosaicing (HRCM-RV) offers accurate presurgical assessment of LM and LMM margins. This prospective study included consecutive patients with biopsy-proven LM and LMM located on the head and neck area who sought consultation for surgical management from March 1, 2016, through March 31, 2017, at the Dermatology Service of the Memorial Sloan Kettering Cancer Center. Thirty-two patients underwent imaging using HRCM-RV, and 22 patients with 23 LM or LMM lesions underwent staged surgery and contributed to the analysis. Clinical lesion size and area, LM and LMM area based on HRCM-RV findings, surgical defect area estimated by HRCM-RV, and observed surg...