Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adults age ≥18 years old

• Histopathology-confirmed Kaposi Sarcoma

• At least 3 skin lesions

• Capable of informed consent

• On treatment for Kaposi Sarcoma

• Adults age ≥18 years old

• Histopathology-confirmed Kaposi Sarcoma

• Capable of informed consent

• Initiating treatment for Kaposi Sarcoma

Locations
Other Locations
Kenya
Kenya Medical Research Institute
RECRUITING
Kisumu
Uganda
Infectious Diseases Institute, Makerere University
RECRUITING
Kampala
Contact Information
Primary
Thomas Odeny, MBChB, MPH, PhD
odeny@wustl.edu
314-273-3022
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 100
Treatments
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.
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.
Sponsors
Leads: Washington University School of Medicine
Collaborators: Makerere University, Kenya Medical Research Institute, Pensievision, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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