Precision Imaging to Evaluate Kaposi Sarcoma

Not Applicable

Recruiting

• Conditions: Kaposi Sarcoma

• Registration Number: NCT06898203
• Lead Sponsor: Washington University School of Medicine

Brief Summary

AIM 1:

In Uganda and Kenya, Kaposi Sarcoma (KS) is one of the most common cancers and a leading cause of cancer-related deaths in men. However, tracking how well patients are responding to treatment is challenging, especially in busy clinics. Doctors must measure the size and changes in the areas affected by the cancer by hand, which can take a lot of time and can vary depending on the doctor. This method does not work well for patients with dark skin, which can lead to biases in treatment compared to patients with fairer skin.

To solve this problem, the investigators suggest the use of a simple, low-cost device that uses Artificial Intelligence (AI), the SkinScan3D (SS3D) device, to measure the cancer spots accurately and monitor changes over time. The goal of this study is to improve the SkinScan3D (SS3D) tool and the how it is used. The investigators will do this by talking to healthcare workers and patients, giving them surveys, and holding design workshops. The feedback from these activities will be shared with the device maker and local research teams to make the device better and ensure it is used properly.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-27
• Study Start: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Primary Completion: 2028-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only	Approximately 3 months	Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.
Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only	Approximately 3 months	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.
Acceptability - Aim 3 Only	6 months	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.
Appropriateness - Aim 3 Only	6 months	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.
Device usability - Aim 3 Only	6 months	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.
Feasibility - Aim 3 Only	6 months	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.

Trial Locations

Locations (2)

Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya

Infectious Diseases Institute, Makerere University; 🇺🇬 Kampala, Uganda