Clinical Trial: Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Brief Summary: The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.

Detailed Summary: The investigators will perform a cross-sectional study of 500 patients in routine clinical care settings who are suspected to have KS on clinical grounds and for whom skin punch biopsy and histopathological examination is indicated as part of standard of care. Patients will be evaluated with both the gold standard for diagnosis of KS (skin punch biopsy followed by histopathology) and portable confocal microscopy.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy [ Time Frame: Approximately 20 minutes (10 minutes for in vivo imaging) ]

Confocal microscopy images obtained from the skin lesion will be compared with the corresponding histologic images. Diagnostic accuracy will be tested. No clinical decisions will be made based on confocal microscopy images.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: February 9, 2017
Date Started: March 10, 2017
Date Completion: February 2018
Last Updated: March 21, 2017
Last Verified: March 2017