Back to resultsSmartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Primary Purpose
Kaposi Sarcoma
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Smartphone confocal microscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Kaposi Sarcoma focused on measuring Smartphone confocal microscopy, Kaposi Sarcoma, Point of care diagnosis
Eligibility Criteria
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.
Sites / Locations
- Infectious Diseases Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Smartphone confocal microscopy imaging
Arm Description
Subject's skin lesion will be imaged with the smartphone confocal microscopy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03050788
First Posted
February 9, 2017
Last Updated
October 23, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), Infectious Diseases Institute, Uganda
1. Study Identification
Unique Protocol Identification Number
NCT03050788
Brief Title
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Official Title
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), Infectious Diseases Institute, Uganda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kaposi Sarcoma
Keywords
Smartphone confocal microscopy, Kaposi Sarcoma, Point of care diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
363 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone confocal microscopy imaging
Arm Type
Experimental
Arm Description
Subject's skin lesion will be imaged with the smartphone confocal microscopy.
Intervention Type
Device
Intervention Name(s)
Smartphone confocal microscopy
Intervention Description
Imaging of skin lesion using the smartphone confocal microscopy
Primary Outcome Measure Information:
Title
Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy
Description
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.
Time Frame
Approximately 20 minutes (10 minutes for in vivo imaging)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongkyun Kang, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Diseases Institute
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
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