Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Not Applicable

Completed

• Conditions: Kaposi Sarcoma
• Interventions: Device: Smartphone confocal microscopy

• Registration Number: NCT03050788
• Lead Sponsor: Massachusetts General Hospital

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 Description

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.

Study Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-13
• Study Start: 2017-03-10
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smartphone confocal microscopy imaging	Smartphone confocal microscopy	Subject's skin lesion will be imaged with the smartphone confocal microscopy.

Primary Outcome Measures

Name	Time	Method
Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy	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.

Trial Locations

Locations (1)

Infectious Diseases Institute; 🇺🇬 Kampala, Uganda