Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

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.

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Key information

Conditions

Kaposi Sarcoma DNA Virus Infections Herpesviridae Infections Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Sarcoma Sarcoma, Kaposi Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infectious Diseases Institute

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

i. ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye.

Exclusion criteria

i. Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.

Treatment and study plan

Smartphone confocal microscopy

Device

Imaging of skin lesion using the smartphone confocal microscopy

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Infectious Diseases Institute, Uganda
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Feb 13, 2017
Registry last updated: Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed