Precision Imaging to Evaluate Kaposi Sarcoma
PRIME-KS
Phase II - Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
2 other identifiers
interventional
300
2 countries
2
Brief Summary
AIMS 2 \& 3: In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedStudy Start
First participant enrolled
May 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
Study Completion
Last participant's last visit for all outcomes
November 30, 2029
March 13, 2026
March 1, 2026
2.5 years
March 20, 2025
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.
Approximately 3 months
Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1.
Approximately 3 months
Device usability - Aim 3 Only
Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score.
6 months
Acceptability - Aim 3 Only
Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention.
6 months
Appropriateness - Aim 3 Only
Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness.
6 months
Feasibility - Aim 3 Only
FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from "completely disagree" to "completely agree"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context.
6 months
Study Arms (2)
Aim 2: Patients
OTHERPatients will have three discrete skin lesions measured, with lesion area determined by ACTG criteria utilizing the product of longest perpendicular diameters. Patients will also have five 3D snapshots of each of the three target lesions taken, measuring lesion area automatically using SS3D.
Aim 3: Patients
OTHERProviders will first measure KS lesions using the manual ruler-based method as per usual standard of care for the first three months. After the first three months, providers will switch to using SkinScan3D for KS skin lesion measurement.
Interventions
A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Eligibility Criteria
You may qualify if:
- Adults age ≥18 years old
- Histopathology-confirmed Kaposi Sarcoma
- At least 3 skin lesions
- Capable of informed consent
- On treatment for Kaposi Sarcoma
You may not qualify if:
- Patients not initiating Kaposi Sarcoma treatment
- Very ill patients requiring hospitalization
- Adults age ≥18 years old
- Histopathology-confirmed Kaposi Sarcoma
- Capable of informed consent
- Initiating treatment for Kaposi Sarcoma
- Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2
- Prior or ongoing Kaposi Sarcoma treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- National Cancer Institute (NCI)collaborator
- Pensievisioncollaborator
- Kenya Medical Research Institutecollaborator
- Makerere Universitycollaborator
Study Sites (2)
Kenya Medical Research Institute
Kisumu, Kenya
Infectious Diseases Institute, Makerere University
Kampala, Uganda
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Odeny, MBChB, MPH, PhD
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2025
First Posted
March 27, 2025
Study Start (Estimated)
May 31, 2026
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2029
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- All data associated with study will be made available at the time of the first publication associated with the data. We anticipate that this will occur approximately 12 months following the completion of field work and within the award period. Study data deposited in WURD and QDR will be available to the public in perpetuity. Datasets related to methodological publications will be shared at publication.
- Access Criteria
- Contact Dr. Thomas Odeny
All participants will consent to the sharing of aggregate de-identified quantitative and qualitative data. Any potentially identifying variables will be stripped from the public-use data in compliance with Washington University IRB policies and human subject protections. Participants will have the option to consent to sharing their identifiable survey data for future research and scholarly use as part of a data donation agreement. These identifiable data will be made available as a separate, identifiable dataset in WURD. All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via the WURD or QDR. Data that are determined to be potentially identifying though indirect or deductive disclosure are provided under restricted data contract to users who have a valid research need and meet conditions of use.