Medical Technology Directory

medical technology evaluations at your fingertips

Reflectance Confocal Microscopy for Diagnosis of Cutaneous Melanoma

December 20, 2019

Health Problem: Melanoma is a malignant tumor of melanocytes, the pigment-producing cells of the skin that derive embryonically from the neural crest. This malignant cancer occurs primarily in adults and the most favorable prognoses are obtained when lesions are thin, minimally invasive, and confined to the primary site. Conversely, the probability of cure decreases dramatically if melanoma metastasizes locally via the lymphatics or systemically through the bloodstream. Despite efforts by public health officials to educate the public about the dangers of sunbathing, sunburns, and tanning beds, approximately 96,480 people in the United States will develop melanoma in the year 2019 and approximately 7230 will die from this disease  

Technology Description: Reflectance confocal microscopy (RCM) is a sophisticated, noninvasive microscopic technique that allows examination of intact skin in multiple thin layers. RCM uses a sophisticated microscope that is handheld or connected to a cart via a mechanical arm. The microscope, which is placed directly over a lesion, obtains images by shining a low-powered laser into the skin. Imaging with RCM may enable accurate identification of suspicious skin lesions that are benign and pose no short-term or long-term risk of developing melanoma, allowing safe postponement or avoidance of biopsy or excision.

Controversy: Melanoma is a dangerous cancer and skin biopsies are often so small that no suture is necessary. Tissue samples from biopsy or an excised lesion can be sliced into thin sections and stained to reveal detail more clearly than RCM. Unless RCM detects every melanoma that can be detected by biopsy or excision, a decision to delay biopsy or excision based on RCM may put patients at unnecessary risk. There is no evidence that RCM is sufficiently accurate to be a stand-alone diagnostic test or to obviate the need for surgical biopsy and histopathological examination of suspicious lesions.

Key Questions:

  • What is the diagnostic accuracy of RCM for the detection of melanoma?
  • How does the diagnostic accuracy of RCM immediately after dermoscopy (DM) compare with DM alone?
  • Does the information provided by RCM improve health outcomes?
  • Is RCM associated with any safety issues?
  • Have patient selection criteria been established for RCM?