Clinical trial NCT06898203: Precision Imaging to Evaluate Kaposi Sarcoma
Official title: Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kaposi Sarcoma
Keywords: Global Oncology
Kaposi Sarcoma
Affordable Cancer Technologies
Cancer in People with HIV
Human Centered Design
Discrete Choice Experiment
Medical devices
Low-cost design
Global health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Pensievision
name: Kenya Medical Research Institute
name: Makerere University
First posted: 2025-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
timeFrame: Approximately 3 months
measure: Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
timeFrame: Approximately 3 months
measure: Device usability - Aim 3 Only
timeFrame: 6 months
measure: Acceptability - Aim 3 Only
timeFrame: 6 months
measure: Appropriateness - Aim 3 Only
timeFrame: 6 months
measure: Feasibility - Aim 3 Only
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
city: Kampala
country: Uganda
facility: Infectious Diseases Institute, Makerere University
Study officials:
affiliation: Washington University School of Medicine
name: Thomas Odeny, MBChB, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: