Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS)

Phase II - Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kaposi Sarcoma
• Intervention / Treatment: Device: SkinScan3D

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Odeny, MBChB, MPH, PhD; Phone Number: 314-273-3022; Email: odeny@wustl.edu

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute
    • Contact: Elizabeth Bukusi, MBChB, MMED, MPH, PhD; Phone Number: +254 0722 205 901; Email: ebukusi@kemri.go.ke
    • Principal Investigator: Elizabeth Bukusi, MBChB, MMED, MPH, PhD
    • Sub-Investigator: Victor Mudhune, Bpharm
• Uganda
  • Kampala, Uganda
    • Infectious Diseases Institute, Makerere University
    • Contact: Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA); Phone Number: +256 772 621181; Email: aseeere@idi.co.ug
    • Principal Investigator: Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA)
    • Sub-Investigator: Fred Okuku, MBChB, MMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria - Aim 2 (Patients):

• Adults age ≥18 years old
• Histopathology-confirmed Kaposi Sarcoma
• At least 3 skin lesions
• Capable of informed consent
• On treatment for Kaposi Sarcoma

Exclusion Criteria - Aim 2 (Patients):

• Patients not initiating Kaposi Sarcoma treatment
• Very ill patients requiring hospitalization

Inclusion Criteria - Aim 3 (Patients):

• Adults age ≥18 years old
• Histopathology-confirmed Kaposi Sarcoma
• Capable of informed consent
• Initiating treatment for Kaposi Sarcoma

Exclusion Criteria - Aim 3 (Patients):

• Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2
• Prior or ongoing Kaposi Sarcoma treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aim 2: Patients; Patients 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.	Device: SkinScan3D; A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).; Other Names: SS3D
Other: Aim 3: Patients; Providers 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.	Device: SkinScan3D; A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).; Other Names: SS3D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); Makerere University; Kenya Medical Research Institute; Pensievision
• Investigators: Principal Investigator: Thomas Odeny, MBChB, MPH, PhD, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Global health; Kaposi Sarcoma; Discrete Choice Experiment; Medical devices; Human Centered Design; Global Oncology; Affordable Cancer Technologies; Cancer in People with HIV; Low-cost design
• Additional Relevant MeSH Terms: Neoplasms; Infections; Virus Diseases; Neoplasms by Histologic Type; DNA Virus Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Herpesviridae Infections; Neoplasms, Vascular Tissue; Sarcoma, Kaposi
• Other Study ID Numbers: 202604055; U01CA292765 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Contact Dr. Thomas Odeny
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No