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Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: A multicenter study

https://doi.org/10.1016/j.jaad.2004.06.028Get rights and content

Background

The current standard diagnostic procedure for basal cell carcinoma (BCC) is histologic examination after invasive biopsy. Reflectance-mode confocal microscopy (RCM) offers noninvasive high-resolution imaging of human skin in vivo.

Objective

The objective of this study was to explore the sensitivity and specificity of RCM for diagnosis of BCC.

Methods

This was a retrospective study of RCM images from 4 institutions of 152 skin lesions representing a variety of benign and malignant diagnoses. These 152 lesions were examined clinically, with biopsies recorded for all the 83 BCCs detected. Based on a previous study, a set of 5 histologically correlated confocal imaging criteria for diagnosing BCC was established, eg, the presence of elongated monomorphic nuclei. Blinded retrospective analysis of the images from the 152 lesions was carried out by a single novice reviewer to determine the sensitivity and specificity of these 5 RCM criteria for diagnosing BCC. The accuracy of combining the probability of BCC based on examination of clinical photographs with the predicted probability of BCC based on confocal criteria was also evaluated.

Results

The presence of two or more criteria is 100% sensitive for the diagnosis of BCC, and with 4 or more RCM criteria present the specificity was 95.7% and sensitivity was 82.9%. These results were found to have little variability across study sites and across BCC subtypes. The combination of RCM with photography-based predictions of clinical probability of BCC significantly improved the accuracy for noninvasive diagnosis of BCC.

Conclusion

RCM offers a sensitive and specific tool for the noninvasive diagnosis of BCC in vivo.

Section snippets

Patients

This was a retrospective multicenter international study performed at the following 4 centers: Wellman Laboratories of Photomedicine at Massachusetts General Hospital in Boston; the Division of Dermatology at Loma Linda University Medical School in Loma Linda, Calif; the Dermatology Service at Hospital Guadalajara at Alcala University in Madrid, Spain; and the private practice of Dermatology and Dermatologic Surgery in Rochester, NY.

In all, 145 patients with 152 skin lesions were recruited for

Characteristics of the data set

The distribution of the 152 lesions in terms of gender of the patient, topographic location, dermatologic diagnoses represented, and BCC subtypes are shown in Table I. Of particular significance is the total number of BCC diagnoses in this dataset (No. 83), which gives us a confidence level of 95% and a maximum estimation error of 6%. This means that the number of BCC lesions in our study is sufficient to confidently calculate sensitivity and specificity with a maximum error of estimation of 6%

Discussion

RCM is a promising noninvasive, high-resolution imaging tool that evaluates the skin in vivo at the level of good histologic detail. This retrospective study was conducted as a multicenter effort to estimate the sensitivity and specificity of RCM for the in vivo diagnosis of BCC.

We found that RCM is sensitive and specific for the in vivo diagnosis of BCC, with the presence of polarized nuclei being both the most sensitive and specific RCM criterion. We found that the presence of 4 or more

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    Supported in part by National Institutes of Health National Institute for Occupational Safety and Health grant RO1 OH04029.

    Disclosure: Dr Goldgeier was a member of the Scientific Advisory Board of Lucid Inc, the company that commercialized the imaging system used for real-time reflectance-mode confocal laser scanning microscopy. In addition, the imaging system used in some of the centers was originally provided by this company.

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