Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Kaposi Sarcoma Clinical Trial

Official title:

Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050788
• Other study ID #: 2016P002672
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: October 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kaposi Sarcoma
• Sarcoma
• Sarcoma, Kaposi

Intervention

Device:
• Smartphone confocal microscopy
Imaging of skin lesion using the smartphone confocal microscopy

Locations

Country	Name	City	State
Uganda	Infectious Diseases Institute	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Infectious Diseases Institute, Uganda, National Institutes of Health (NIH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy	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.	Approximately 20 minutes (10 minutes for in vivo imaging)