Precision Imaging to Evaluate Kaposi Sarcoma

Washington University School of Medicine100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Kaposi Sarcoma

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Precision Imaging to Evaluate Kaposi Sarcoma

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Central Contacts