Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS)

The Washington University

Status: Enrolling

Conditions: Kaposi Sarcoma

Treatments: Device: SkinScan3D

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06898203

U01CA292765 (U.S. NIH Grant/Contract)

202411179

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Aim 2: Patients

Other group

Description:

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.

Treatment:

Device: SkinScan3D

Aim 3: Patients

Other group

Description:

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.

Treatment:

Device: SkinScan3D